Medical devices and methods

ABSTRACT

Methods and devices to monitor an analyte in body fluid are provided. Embodiments include continuous or discrete acquisition of analyte related data from a transcutaneously positioned in vivo analyte sensor automatically or upon request from a user.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 12/807,278 filed Aug. 31, 2010, which claims priority under §35 U.S.C. 119(e) to U.S. Provisional Application No. 61/238,581 filedAug. 31, 2009, U.S. Provisional Application No. 61/247,519 filed Sep.30, 2009, U.S. Provisional Application No. 61/247,514 filed Sep. 30,2009, U.S. Provisional Application No. 61/247,508 filed Sep. 30, 2009,U.S. Provisional Application No. 61/256,925 filed Oct. 30, 2009, U.S.Provisional Application No. 61/291,326 filed Dec. 30, 2009, and U.S.Provisional Application No. 61/299,924 filed Jan. 29, 2010, thedisclosures of each of which are incorporated herein by reference forall purposes.

INCORPORATION BY REFERENCE

Patents, applications and/or publications described herein, includingthe following patents, applications and/or publications are incorporatedherein by reference for all purposes: U.S. Pat. Nos. 4,545,382;4,711,245; 5,262,035; 5,262,305; 5,264,104; 5,320,715; 5,356,786;5,509,410; 5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551;5,822,715; 5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676;6,121,009; 6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752;6,270,455; 6,284,478; 6,299,757; 6,338,790; 6,377,894; 6,461,496;6,503,381; 6,514,460; 6,514,718; 6,540,891; 6,560,471; 6,579,690;6,591,125; 6,592,745; 6,600,997; 6,605,200; 6,605,201; 6,616,819;6,618,934; 6,650,471; 6,654,625; 6,676,816; 6,730,200; 6,736,957;6,746,582; 6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545;6,932,892; 6,932,894; 6,942,518; 7,041,468; 7,167,818; and 7,299,082;U.S. Published Application Nos. 2004/0186365, now U.S. Pat. No.7,811,231; 2005/0182306, now U.S. Pat. No. 8,771,183; 2006/0025662, nowU.S. Pat. No. 7,740,581; 2006/0091006; 2007/0056858, now U.S. Pat. No.8,298,389; 2007/0068807, now U.S. Pat. No. 7,846,311; 2007/0095661;2007/0108048, now U.S. Pat. No. 7,918,975; 2007/0199818, now U.S. Pat.No. 7,811,430; 2007/0227911, now U.S. Pat. No. 7,887,682; 2007/0233013;2008/0066305, now U.S. Pat. No. 7,895,740; 2008/0081977, now U.S. Pat.No. 7,618,369; 2008/0102441, now U.S. Pat. No. 7,822,557; 2008/0148873,now U.S. Pat. No. 7,802,467; 2008/0161666; 2008/0267823; and2009/0054748, now U.S. Pat. No. 7,885,698; U.S. patent application Ser.No. 11/461,725, now U.S. Pat. No. 7,866,026; Ser. Nos. 12/131,012;12/393,921, 12/242,823, now U.S. Pat. No. 8,219,173; Ser. No.12/363,712, now U.S. Pat. No. 8,346,335; Ser. Nos. 12/495,709;12/698,124; 12/698,129; 12/714,439; 12/794,721, now U.S. Pat. No.8,595,607; and Ser. No. 12/842,013, and U.S. Provisional ApplicationNos. 61/238,646, 61/246,825, 61/247,516, 61/249,535, 61/317,243,61/345,562, and 61/361,374.

BACKGROUND

The detection and/or monitoring of glucose levels or other analytes,such as lactate, oxygen, A1C, or the like, in certain individuals isvitally important to their health. For example, the monitoring ofglucose is particularly important to individuals with diabetes.Diabetics generally monitor glucose levels to determine if their glucoselevels are being maintained within a clinically safe range, and may alsouse this information to determine if and/or when insulin is needed toreduce glucose levels in their bodies or when additional glucose isneeded to raise the level of glucose in their bodies.

Growing clinical data demonstrates a strong correlation between thefrequency of glucose monitoring and glycemic control. Despite suchcorrelation, many individuals diagnosed with a diabetic condition do notmonitor their glucose levels as frequently as they should due to acombination of factors including convenience, testing discretion, painassociated with glucose testing, and cost.

Devices have been developed for the automatic monitoring of analyte(s),such as glucose, in bodily fluid such as in the blood stream or ininterstitial fluid (“ISF”), or other biological fluid. Some of theseanalyte measuring devices are configured so that at least a portion ofthe devices are positioned below a skin surface of a user, e.g., in ablood vessel or in the subcutaneous tissue of a user, so that themonitoring is accomplished in vivo.

With the continued development of analyte monitoring devices andsystems, there is a need for such analyte monitoring devices, systems,and methods, as well as for processes for manufacturing analytemonitoring devices and systems that are cost effective, convenient, andwith reduced pain, provide discreet monitoring to encourage frequentanalyte monitoring to improve glycemic control.

SUMMARY

Embodiments of the subject disclosure include in vivo analyte monitoringdevices, systems, kits, and processes of analyte monitoring and makinganalyte monitoring devices, systems and kits. Included are on-body(i.e., at least a portion of a device, system or a component thereof ismaintained on the body of a user to monitor an analyte), physiologicalmonitoring devices configured for real time measurement/monitoring ofdesired analyte level such as a glucose level over one or morepredetermined time periods such as one or more predetermined monitoringtime periods. Embodiments include transcutaneously positioned analytesensors that are electrically coupled with electronics provided in ahousing that is designed to be attached to the body of a user, forexample, to a skin surface of a user, during the usage life of theanalyte sensors or predetermined monitoring time periods. For example,an on body electronics assembly includes electronics that areoperatively coupled to an analyte sensor and provided in a housing forplacement on the body of a user.

Such device and system with analyte sensors provide continuous orperiodic analyte level monitoring that is executed automatically, orsemi-automatically by control logic or routines programmed orprogrammable in the monitoring devices or systems. As used herein,continuous, automatic, and/or periodic monitoring refer to the in vivomonitoring or detection of analyte levels with transcutaneouslypositioned analyte sensors.

In certain embodiments, the results of the in vivo monitored analytelevel are automatically communicated from an electronics unit to anotherdevice or component of the system. That is, when the results areavailable, the results are automatically transmitted to a display device(or other user interaction device) of the system, for example, accordingto a fixed or dynamic data communication schedule executed by thesystem. In other embodiments, the results of the in vivo monitoredanalyte level are not automatically communicated, transferred or outputto one or more device or component of the system. In such embodiments,the results are provided only in response to a query to the system. Thatis, the results are communicated to a component or a device of thesystem only in response to the query or request for such results. Incertain embodiments, the results of the in vivo monitoring may be loggedor stored in a memory of the system and only communicated or transferredto another device or component of the system after the one or morepredetermined monitoring time periods.

Embodiments include software and/or hardware to transform any one of thedevices, components or systems into any one of the other devices,components or systems, where such transformation may beuser-configurable after manufacture. Transformation modules that includehardware and/or software to accomplish such transformation may bemateable to a given system to transform it.

Embodiments include electronics coupled to analyte sensors that providefunctionalities to operate the analyte sensors for monitoring analytelevels over a predetermined monitoring time period such as for example,about 30 days (or more in certain embodiments), about 14 days, about 10days, about 5 days, about 1 day, less than about 1 day. In certainembodiments, the usage life of each analyte sensor may be the same as ordifferent from the predetermined monitoring time periods. Components ofthe electronics to provide the functionalities to operate the analytesensors in certain embodiments include control logic or microprocessorscoupled to a power supply such as a battery to drive the in vivo analytesensors to perform electrochemical reactions to generate resultingsignals that correspond to the monitored analyte levels.

Electronics may also include other components such as one or more datastorage units or memory (volatile and/or non volatile), communicationcomponent(s) to communicate information corresponding to the in vivomonitored analyte level to a display device automatically when theinformation is available, or selectively in response to a request forthe monitored analyte level information. Data communication betweendisplay devices and the electronics units coupled to the sensor may beimplemented serially (e.g., data transfer between them are not performedat the same time), or in parallel. For example, the display device maybe configured to transmit a signal or data packet to the electronicscoupled to the sensor, and upon receipt of the transmitted signal ordata packet, the electronics coupled to the sensor communicates back tothe display device. In certain embodiments, a display device may beconfigured to provide RF power and data/signals continually, anddetecting or receiving one or more return data packet or signal fromelectronics coupled to the sensor when it is within a predetermined RFpower range from the display device. In certain embodiments, the displaydevice and the electronics coupled to the sensor may be configured totransmit one or more data packets at the same time.

In certain embodiments, the one or more data storage units or memorystores data under the control of the electronics. In certainembodiments, the one or more data storage units or memory stores dataaccording to a rolling data storage protocol executed by the controllogic or microprocessors of the electronics. The data may be rolledaccording to time and/or prioritization, or otherwise. For example, arolling data storage protocol may include a First-In/First-Out (FIFO)algorithm, First-In/Last-Out (FILO) algorithm, Last-In/First-Out (LIFO)algorithm, Last-In/Last-Out (LILO) algorithm. For example, embodimentsinclude displacing the oldest stored data with most recent data in aniterative manner, or other rolling data protocol variations thereof.

Embodiments include self powered in vivo analyte sensors that do notrequire a separate power supply to operate the analyte sensors for thedetection or monitoring of the analyte level. In other words, selfpowered sensors that provide their own power to operate and do notrequire any other power supply to monitor analyte in vivo are described.

Embodiments also include electronics programmed to store or log in theone or more data storage units or a memory data associated with themonitored analyte level over the sensor usage life or during amonitoring time period. During the monitoring time period, informationcorresponding to the monitored analyte level may be stored but notdisplayed or output during the sensor usage life, and the stored datamay be later retrieved from memory at the end of the sensor usage lifeor after the expiration of the predetermined monitoring time period,e.g., for clinical analysis, therapy management, etc.

In certain embodiments, the predetermined monitoring time period may bethe same as the sensor usage life time period such that when an analytesensor usage life expires (thus no longer used for in vivo analyte levelmonitoring), the predetermined monitoring time period ends. In certainother embodiments, the predetermined monitoring time period may includemultiple sensor usage life time periods such that when an analyte sensorusage life expires, the predetermined monitoring time period has notended, and the expired analyte sensor is replaced with another analytesensor during the same predetermined monitoring time period. Thepredetermined monitoring time period may include the replacement ofmultiple analyte sensors for use.

In certain embodiments, in addition to the monitored analyte levelinformation, other information may be communicated to a device, systemor a component thereof, such as, but not limited to, monitoredtemperature information, heart rate, one or more biomarkers such asHbA1C or the like, stored analyte level information spanning a timeperiod, e.g., the past 1 second to about 48 hours, e.g., the past 1minute to about 24 hours, e.g., the past about 1 minute to about 10hours, e.g., the past about 8 hours, or the past about 2 hours, or thepast about 1 hour, or the past about 30 minutes, or the past about 15minutes.

In certain embodiments, temperature (in vivo and/or skin and/or ambient)information may be obtained and stored in memory, e.g., to be used in analgorithm to compensate for temperature dependent inaccuracies inmonitored analyte levels.

Analyte level trend information may be generated or constructed based onstored analyte level information spanning a time period (e.g.,corresponding to a temperature time period, or other) and communicatedto the display device. The trend information may be output graphicallyand/or audibly and/or tactilely, and/or numerically and/or otherwisepresented on a user interface of the display device to provideindication of the analyte level variation during this time period.

Embodiments include wirelessly communicating analyte level informationfrom an on body electronics device to a second device such as a displaydevice. Examples of communication protocols between on body electronicsand the display device may include radio frequency identification (RFID)protocols or RF communication protocols. Exemplary RFID protocolsinclude but are not limited to near field communication protocols thatinclude short communication ranges (e.g., about 12 inches or less, orabout 6 inches or less, or about 3 inches or less, or about 2 inches orless), high frequency wireless communication protocols, far fieldcommunication protocols (e.g., using ultra high frequency (UHF)communication systems) for providing signals or data from on bodyelectronics to display devices.

Communication protocols may use 433 MHz frequency, 13.56 MHz frequency,2.45 GHz frequency, or other suitable frequencies for wirelesscommunication between the on body electronics that includes electronicscoupled to an analyte sensor, and display devices and/or other devicessuch as a personal computer. While certain data transmission frequenciesand/or data communication ranges are described above, within the scopeof the present disclosure, other data suitable data transmissionfrequencies and/or data communication ranges may be used between thevarious devices in the analyte monitoring system.

Embodiments include data management systems including, for example, adata network and/or personal computer and/or a server terminal and/orone or more remote computers that are configured to receive collected orstored data from the display device for presenting analyte informationand/or further processing in conjunction with the physiologicalmonitoring for health management. For example, a display device mayinclude one or more communication ports (hard wired or wireless) forconnection to a data network or a computer terminal to transfercollected or stored analyte related data to another device and/orlocation. Analyte related data in certain embodiment are directlycommunicated from the electronics coupled to the analyte sensor to apersonal computer, server terminal, and/or remote computers over thedata network.

In certain embodiments, calibration “invisible” systems and methods areprovided that determine clinically accurate analyte concentrations atleast over the predetermined sensing period of analyte sensor systemswithout obtaining one or more independent analyte measurements (e.g.,without using an in vitro test strip or other reference device) forcalibration of generated analyte related signal from the analyte sensorduring the usage life of the sensor, i.e., post-manufacture. In otherwords, once the analyte sensors are positioned in the body of the user,control logic or microprocessors in the electronics, or themicroprocessors in the display device include one or more algorithms orprogramming to accurately convert or correlate signals related to thesensed analyte (e.g., in nA, counts, or other appropriate units) to acorresponding analyte level (e.g., converted to an analyte level inmg/dL or other appropriate units) without a reference value provided tothe system, rendering sensor calibration “invisible” to the user suchthat the system does not require any human intervention for analytesensor calibration.

These and other features, objects and advantages of the presentdisclosure will become apparent to those persons skilled in the art uponreading the details of the present disclosure as more fully describedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates analyte monitoring system for real time analyte(e.g., glucose) measurement, data acquisition and/or processing incertain embodiments;

FIGS. 2A-2B are perspective and cross-sectional perspective views,respectively, of the housing including analyte sensor and on bodyelectronics of system in FIG. 1 in certain embodiments;

FIG. 3 illustrates a printed circuit board (PCB) of on body electronicsin certain embodiments.

FIG. 4A illustrates a side view of the housing including an analytesensor and sensor electronics in certain embodiments;

FIG. 4B illustrates a side view of a PCB of the on body electronicsassembled with an analyte sensor in certain embodiments;

FIG. 5 is a perspective view of the electronics assembly shown in FIG.4B with separated components including the PCB and the analyte sensor;

FIG. 6 is a component view of the analyte sensor and interconnectcomponents of FIG. 5 in certain embodiments;

FIGS. 7A-7B are perspective views of the interconnect component of FIG.5 in certain embodiments

FIGS. 8A-8D illustrate on body electronics including a moduleinterconnect in certain embodiments;

FIGS. 9A-9J illustrate on body electronics assembly including analytesensor, components for connection to a PCB of on body electronics incertain embodiments;

FIG. 10A illustrates a top planar view of antenna and electronic circuitlayout of the on body electronics of the analyte monitoring system 100of FIG. 1 in certain embodiments;

FIG. 10B illustrates a cross sectional view of antenna and electroniccircuit layout of the on body electronics of the analyte monitoringsystem 100 of FIG. 1 in certain embodiments;

FIG. 11 illustrates a top planar view of the antenna layout on thecircuit board of the on body electronics in certain embodiments;

FIGS. 12A-12C illustrate an antenna configuration of the on bodyelectronics in certain embodiments;

FIG. 13 is a schematic of an on body electronics in the analytemonitoring system 100 of FIG. 1 in certain embodiments;

FIGS. 14A-14E illustrate on body electronics configurations of analytemonitoring system 100 of FIG. 1 in certain embodiments;

FIG. 15 is a block diagram of illustrating an on body electronics ofanalyte monitoring system 100 of FIG. 1 in certain embodiments;

FIG. 16 is a block diagram of on body electronics in analyte monitoringsystem 100 of FIG. 1 in certain embodiments;

FIG. 17 is a schematic of an on body electronics including an inductiongenerator for use in certain embodiments;

FIG. 18A illustrates a block diagram of the wireless turn on mechanismfor analyte monitoring system in certain embodiments;

FIG. 18B illustrates an exemplary circuit schematic of wireless turn onmechanism of FIG. 18A in certain embodiments;

FIG. 19 is a flowchart illustrating data/command exchange betweendisplay device and on body electronics for executing wireless turn onprocedure in certain embodiments;

FIG. 20 is a block diagram of the display device of FIG. 1 in certainembodiments;

FIG. 21A is a schematic of the display device of FIG. 1 in certainembodiments;

FIG. 21B is a schematic of the display device of FIG. 1 in certainembodiments;

FIGS. 22 and 23 are diagram and flowchart, respectively, illustrating aprocess for implementing a wireless communication in the system of FIG.1 in certain embodiments;

FIG. 24 is a flowchart illustrating a routine for determining the sensorexpiration information by display device 120 for communication to onbody electronics in certain embodiments;

FIGS. 25-26 are functional block diagrams illustrating analyte sensordata processing routines in certain embodiments;

FIGS. 27A-27D are flowcharts illustrating analyte sensor data processingroutines in certain embodiments;

FIG. 28 is a flowchart illustrating analyte sensor data acquisitionnotification routine in certain embodiments;

FIG. 29 is a flowchart illustrating manufacturing based analyte sensorcalibration implemented in sensor data processing in certainembodiments; and

FIG. 30A-30D illustrates an embodiment of the analyte data acquisitionmodule for use with a display device in certain embodiments.

DETAILED DESCRIPTION

Before the present disclosure is described in detail, it is to beunderstood that this disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the disclosure. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges as also encompassed within the disclosure, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the disclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present disclosure, the preferredmethods and materials are now described. All publications mentionedherein are incorporated herein by reference to disclose and describe themethods and/or materials in connection with which the publications arecited.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

The figures shown herein are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity.

Generally, embodiments of the present disclosure relate to in vivomethods and devices for detecting at least one analyte such as glucosein body fluid. Accordingly, embodiments include in vivo analyte sensorsconfigured so that at least a portion of the sensor is positioned in thebody of a user (e.g., within the ISF), to obtain information about atleast one analyte of the body, e.g., transcutaneously positioned inuser's body. In certain embodiments, an in vivo analyte sensor iscoupled to an electronics unit that is maintained on the body of theuser such as on a skin surface, where such coupling provides on body, invivo analyte sensor electronics assemblies.

In certain embodiments, analyte information is communicated from a firstdevice such as an on body electronics unit to a second device which mayinclude user interface features, including a display, and/or the like.Information may be communicated from the first device to the seconddevice automatically and/or continuously when the analyte information isavailable, or may not be communicated automatically and/or continuously,but rather stored or logged in a memory of the first device.Accordingly, in many embodiments of the system, analyte informationderived by the sensor/on body electronics (for example, on bodyelectronics assembly) is made available in a user-usable or viewableform only when queried by the user such that the timing of datacommunication is selected by the user.

In this manner, analyte information is only provided or evident to auser (provided at a user interface device) when desired by the user eventhough an in vivo analyte sensor automatically and/or continuouslymonitors the analyte level in vivo, i.e., the sensor automaticallymonitors analyte such as glucose on a pre-defined time interval over itsusage life. For example, an analyte sensor may be positioned in vivo andcoupled to on body electronics for a given sensing period, e.g., about14 days. In certain embodiments, the sensor-derived analyte informationis automatically communicated from the sensor electronics assembly to aremote monitor device or display device for output to a user throughoutthe 14 day period according to a schedule programmed at the on bodyelectronics (e.g., about every 1 minute or about every 5 minutes orabout every 10 minutes, or the like). In certain embodiments,sensor-derived analyte information is only communicated from the sensorelectronics assembly to a remote monitor device or display device atuser-determined times, e.g., whenever a user decides to check analyteinformation. At such times, a communications system is activated andsensor-derived information is then sent from the on body electronics tothe remote device or display device.

In still other embodiments, the information may be communicated from thefirst device to the second device automatically and/or continuously whenthe analyte information is available, and the second device stores orlogs the received information without presenting or outputting theinformation to the user. In such embodiments, the information isreceived by the second device from the first device when the informationbecomes available (e.g., when the sensor detects the analyte levelaccording to a time schedule). However, the received information isinitially stored in the second device and only output to a userinterface or an output component of the second device (e.g., display)upon detection of a request for the information on the second device.

Accordingly, in certain embodiments once a sensor electronics assemblyis placed on the body so that at least a portion of the in vivo sensoris in contact with bodily fluid such as ISF and the sensor iselectrically coupled to the electronics unit, sensor derived analyteinformation may be communicated from the on body electronics to adisplay device on-demand by powering on the display device (or it may becontinually powered), and executing a software algorithm stored in andaccessed from a memory of the display device, to generate one or morerequest commands, control signal or data packet to send to the on bodyelectronics. The software algorithm executed under, for example, thecontrol of the microprocessor or application specific integrated circuit(ASIC) of the display device may include routines to detect the positionof the on body electronics relative to the display device to initiatethe transmission of the generated request command, control signal and/ordata packet.

Display devices may also include programming stored in memory forexecution by one or more microprocessors and/or ASICs to generate andtransmit the one or more request command, control signal or data packetto send to the on body electronics in response to a user activation ofan input mechanism on the display device such as depressing a button onthe display device, triggering a soft button associated with the datacommunication function, and so on. The input mechanism may bealternatively or additionally provided on or in the on body electronicswhich may be configured for user activation. In certain embodiments,voice commands or audible signals may be used to prompt or instruct themicroprocessor or ASIC to execute the software routine(s) stored in thememory to generate and transmit the one or more request command, controlsignal or data packet to the on body device. In the embodiments that arevoice activated or responsive to voice commands or audible signals, onbody electronics and/or display device includes a microphone, a speaker,and processing routines stored in the respective memories of the on bodyelectronics and/or the display device to process the voice commandsand/or audible signals. In certain embodiments, positioning the on bodydevice and the display device within a predetermined distance (e.g.,close proximity) relative to each other initiates one or more softwareroutines stored in the memory of the display device to generate andtransmit a request command, control signal or data packet.

Different types and/or forms and/or amounts of information may be sentfor each on demand reading, including but not limited to one or more ofcurrent analyte level information (i.e., real time or the most recentlyobtained analyte level information temporally corresponding to the timethe reading is initiated), rate of change of an analyte over apredetermined time period, rate of the rate of change of an analyte(acceleration in the rate of change), historical analyte informationcorresponding to analyte information obtained prior to a given readingand stored in memory of the assembly. Some or all of real time,historical, rate of change, rate of rate of change (such as accelerationor deceleration) information may be sent to a display device for a givenreading. In certain embodiments, the type and/or form and/or amount ofinformation sent to a display device may be preprogrammed and/orunchangeable (e.g., preset at manufacturing), or may not bepreprogrammed and/or unchangeable so that it may be selectable and/orchangeable in the field one or more times (e.g., by activating a switchof the system, etc). Accordingly, in certain embodiments, for each ondemand reading, a display device will output a current (real time)sensor-derived analyte value (e.g., in numerical format), a current rateof analyte change (e.g., in the form of an analyte rate indicator suchas an arrow pointing in a direction to indicate the current rate), andanalyte trend history data based on sensor readings acquired by andstored in memory of on body electronics (e.g., in the form of agraphical trace). Additionally, the on skin or sensor temperaturereading or measurement associated with each on demand reading may becommunicated from the on body electronics to the display device. Thetemperature reading or measurement, however, may not be output ordisplayed on the display device, but rather, used in conjunction with asoftware routine executed by the display device to correct or compensatethe analyte measurement output to the user on the display device.

As described, embodiments include in vivo analyte sensors and on bodyelectronics that together provide body wearable sensor electronicsassemblies. In certain embodiments, in vivo analyte sensors are fullyintegrated with on body electronics (fixedly connected duringmanufacture), while in other embodiments they are separate butconnectable post manufacture (e.g., before, during or after sensorinsertion into a body). On body electronics may include an in vivoglucose sensor, electronics, battery, and antenna encased (except forthe sensor portion that is for in vivo positioning) in a waterproofhousing that includes or is attachable to an adhesive pad. In certainembodiments, the housing withstands immersion in about one meter ofwater for up to at least 30 minutes. In certain embodiments, the housingwithstands continuous underwater contact, e.g., for longer than about 30minutes, and continues to function properly according to its intendeduse, e.g., without water damage to the housing electronics where thehousing is suitable for water submersion.

Embodiments include sensor insertion devices, which also may be referredto herein as sensor delivery units, or the like. Insertion devices mayretain on body electronics assemblies completely in an interiorcompartment, i.e., an insertion device may be “pre-loaded” with on bodyelectronics assemblies during the manufacturing process (e.g., on bodyelectronics may be packaged in a sterile interior compartment of aninsertion device). In such embodiments, insertion devices may formsensor assembly packages (including sterile packages) for pre-use or newon body electronics assemblies, and insertion devices configured toapply on body electronics assemblies to recipient bodies.

Embodiments include portable handheld display devices, as separatedevices and spaced apart from an on body electronics assembly, thatcollect information from the assemblies and provide sensor derivedanalyte readings to users. Such devices may also be referred to asmeters, readers, monitors, receivers, human interface devices,companions, or the like. Certain embodiments may include an integratedin vitro analyte meter. In certain embodiments, display devices includeone or more wired or wireless communications ports such as USB, serial,parallel, or the like, configured to establish communication between adisplay device and another unit (e.g., on body electronics, power unitto recharge a battery, a PC, etc). For example, a display devicecommunication port may enable charging a display device battery with arespective charging cable and/or data exchange between a display deviceand its compatible informatics software.

Compatible informatics software in certain embodiments include, forexample, but not limited to stand alone or network connection enableddata management software program, resident or running on a displaydevice, personal computer, a server terminal, for example, to performdata analysis, charting, data storage, data archiving and datacommunication as well as data synchronization. Informatics software incertain embodiments may also include software for executing fieldupgradeable functions to upgrade firmware of a display device and/or onbody electronics unit to upgrade the resident software on the displaydevice and/or the on body electronics unit, e.g., with versions offirmware that include additional features and/or include software bugsor errors fixed, etc.

Embodiments may include a haptic feedback feature such as a vibrationmotor or the like, configured so that corresponding notifications (e.g.,a successful on-demand reading received at a display device), may bedelivered in the form of haptic feedback.

Embodiments include programming embedded on a computer readable medium,i.e., computer-based application software (may also be referred toherein as informatics software or programming or the like) thatprocesses analyte information obtained from the system and/or userself-reported data. Application software may be installed on a hostcomputer such as a mobile telephone, PC, an Internet-enabled humaninterface device such as an Internet-enabled phone, personal digitalassistant, or the like, by a display device or an on body electronicsunit. Informatics programming may transform data acquired and stored ona display device or on body unit for use by a user.

Embodiments of the subject disclosure are described primarily withrespect to glucose monitoring devices and systems, and methods ofglucose monitoring, for convenience only and such description is in noway intended to limit the scope of the disclosure. It is to beunderstood that the analyte monitoring system may be configured tomonitor a variety of analytes at the same time or at different times.

For example, analytes that may be monitored include, but are not limitedto, acetyl choline, amylase, bilirubin, cholesterol, chorionicgonadotropin, creatine kinase (e.g., CK-MB), creatine, DNA,fructosamine, glucose, glutamine, growth hormones, hormones, ketones,lactate, oxygen, peroxide, prostate-specific antigen, prothrombin, RNA,thyroid stimulating hormone, and troponin. The concentration of drugs,such as, for example, antibiotics (e.g., gentamicin, vancomycin, and thelike), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin,may also be monitored. In those embodiments that monitor more than oneanalyte, the analytes may be monitored at the same or different times,with a single sensor or with a plurality of sensors which may use thesame on body electronics (e.g., simultaneously) or with different onbody electronics.

As described in detail below, embodiments include devices, systems, kitsand/or methods to monitor one or more physiological parameters such as,for example, but not limited to, analyte levels, temperature levels,heart rate, user activity level, over a predetermined monitoring timeperiod. Also provided are methods of manufacturing. Predeterminedmonitoring time periods may be less than about 1 hour, or may includeabout 1 hour or more, e.g., about a few hours or more, e.g., about a fewdays of more, e.g., about 3 or more days, e.g., about 5 days or more,e.g., about 7 days or more, e.g., about 10 days or more, e.g., about 14days or more, e.g., about several weeks, e.g., about 1 month or more. Incertain embodiments, after the expiration of the predeterminedmonitoring time period, one or more features of the system may beautomatically deactivated or disabled at the on body electronicsassembly and/or display device.

For example, a predetermined monitoring time period may begin withpositioning the sensor in vivo and in contact with a body fluid such asISF, and/or with the initiation (or powering on to full operationalmode) of the on body electronics. Initialization of on body electronicsmay be implemented with a command generated and transmitted by a displaydevice in response to the activation of a switch and/or by placing thedisplay device within a predetermined distance (e.g., close proximity)to the on body electronics, or by user manual activation of a switch onthe on body electronics unit, e.g., depressing a button, or suchactivation may be caused by the insertion device, e.g., as described inU.S. patent application Ser. No. 12/698,129 filed on Feb. 1, 2010 andU.S. Provisional Application Nos. 61/238,646, 61/246,825, 61/247,516,61/249,535, 61/317,243, 61/345,562, and 61/361,374, the disclosures ofeach of which are incorporated herein by reference for all purposes.

When initialized in response to a received command from a displaydevice, the on body electronics retrieves and executes from its memorysoftware routine to fully power on the components of the on bodyelectronics, effectively placing the on body electronics in fulloperational mode in response to receiving the activation command fromthe display device. For example, prior to the receipt of the commandfrom the display device, a portion of the components in the on bodyelectronics may be powered by its internal power supply such as abattery while another portion of the components in the on bodyelectronics may be in powered down or low power including no power,inactive mode, or all components may be in an inactive mode, powereddown mode. Upon receipt of the command, the remaining portion (or all)of the components of the on body electronics is switched to active,fully operational mode.

Embodiments of on body electronics may include one or more printedcircuit boards with electronics including control logic implemented inASIC, microprocessors, memory, and the like, and transcutaneouslypositionable analyte sensors forming a single assembly. On bodyelectronics may be configured to provide one or more signals or datapackets associated with a monitored analyte level upon detection of adisplay device of the analyte monitoring system within a predeterminedproximity for a period of time (for example, about 2 minutes, e.g., 1minute or less, e.g., about 30 seconds or less, e.g., about 10 secondsor less, e.g., about 5 seconds or less, e.g., about 2 seconds or less)and/or until a confirmation, such as an audible and/or visual and/ortactile (e.g., vibratory) notification, is output on the display deviceindicating successful acquisition of the analyte related signal from theon body electronics. A distinguishing notification may also be outputfor unsuccessful acquisition in certain embodiments.

In certain embodiments, the monitored analyte level may be correlatedand/or converted to glucose levels in blood or other fluids such as ISF.Such conversion may be accomplished with the on body electronics, but inmany embodiments will be accomplished with display device electronics.In certain embodiments, glucose level is derived from the monitoredanalyte level in the ISF.

Analyte sensors may be insertable into a vein, artery, or other portionof the body containing analyte. In certain embodiments, analyte sensorsmay be positioned in contact with ISF to detect the level of analyte,where the detected analyte level may be used to infer the user's glucoselevel in blood or interstitial tissue.

Embodiments include transcutaneous sensors and also wholly implantablesensors and wholly implantable assemblies in which a single assemblyincluding the analyte sensor and electronics are provided in a sealedhousing (e.g., hermetically sealed biocompatible housing) forimplantation in a user's body for monitoring one or more physiologicalparameters.

Embodiments of In Vivo Analyte Monitoring Systems

FIG. 1 shows an exemplary in vivo-based analyte monitoring system 100 inaccordance with embodiments of the present disclosure. As shown, incertain embodiments, analyte monitoring system 100 includes on bodyelectronics 110 electrically coupled to in vivo analyte sensor 101 (aproximal portion of which is shown in FIG. 1) and attached to adhesivelayer 140 for attachment on a skin surface on the body of a user. Onbody electronics 110 includes on body housing 119, that defines aninterior compartment. Also shown in FIG. 1 is insertion device 150 that,when operated, transcutaneously positions a portion of analyte sensor101 through a skin surface and in fluid contact with ISF, and positionson body electronics 110 and adhesive layer 140 on a skin surface. Incertain embodiments, on body electronics 110, analyte sensor 101 andadhesive layer 140 are sealed within the housing of insertion device 150before use, and in certain embodiments, adhesive layer 140 is alsosealed within the housing or itself provides a terminal seal of theinsertion device 150. Devices, systems and methods that may be used withembodiments herein are described, e.g., in U.S. patent application Ser.No. 12/698,129 and U.S. Provisional Application Nos. 61/238,646,61/246,825, 61/247,516, 61/249,535, 61/317,243, 61/345,562, and61/361,374, the disclosures of each of which are incorporated herein byreference for all purposes.

Referring back to the FIG. 1, analyte monitoring system 100 includesdisplay device 120 which includes a display 122 to output information tothe user, an input component 121 such as a button, actuator, a touchsensitive switch, a capacitive switch, pressure sensitive switch, jogwheel or the like, to input data or command to display device 120 orotherwise control the operation of display device 120. It is noted thatsome embodiments may include display-less devices or devices without anyuser interface components. These devices may be functionalized to storedata as a data logger and/or provide a conduit to transfer data from onbody electronics and/or a display-less device to another device and/orlocation. Embodiments will be described herein as display devices forexemplary purposes which are in no way intended to limit the embodimentsof the present disclosure. It will be apparent that display-less devicesmay also be used in certain embodiments.

In certain embodiments, on body electronics 110 may be configured tostore some or all of the monitored analyte related data received fromanalyte sensor 101 in a memory during the monitoring time period, andmaintain it in memory until the usage period ends. In such embodiments,stored data is retrieved from on body electronics 110 at the conclusionof the monitoring time period, for example, after removing analytesensor 101 from the user by detaching on body electronics 110 from theskin surface where it was positioned during the monitoring time period.In such data logging configurations, real time monitored analyte levelis not communicated to display device 120 during the monitoring periodor otherwise transmitted from on body electronics 110, but rather,retrieved from on body electronics 110 after the monitoring time period.

In certain embodiments, input component 121 of display device 120 mayinclude a microphone and display device 120 may include softwareconfigured to analyze audio input received from the microphone, suchthat functions and operation of the display device 120 may be controlledby voice commands. In certain embodiments, an output component ofdisplay device 120 includes a speaker for outputting information asaudible signals. Similar voice responsive components such as a speaker,microphone and software routines to generate, process and store voicedriven signals may be provided to on body electronics 110.

In certain embodiments, display 122 and input component 121 may beintegrated into a single component, for example a display that candetect the presence and location of a physical contact touch upon thedisplay such as a touch screen user interface. In such embodiments, theuser may control the operation of display device 120 by utilizing a setof pre-programmed motion commands, including, but not limited to, singleor double tapping the display, dragging a finger or instrument acrossthe display, motioning multiple fingers or instruments toward oneanother, motioning multiple fingers or instruments away from oneanother, etc. In certain embodiments, a display includes a touch screenhaving areas of pixels with single or dual function capacitive elementsthat serve as LCD elements and touch sensors.

Display device 120 also includes data communication port 123 for wireddata communication with external devices such as remote terminal(personal computer) 170, for example. Example embodiments of the datacommunication port 123 include USB port, mini USB port, RS-232 port,Ethernet port, Firewire port, or other similar data communication portsconfigured to connect to the compatible data cables. Display device 120may also include an integrated in vitro glucose meter, including invitro test strip port 124 to receive an in vitro glucose test strip forperforming in vitro blood glucose measurements.

Referring still to FIG. 1, display 122 in certain embodiments isconfigured to display a variety of information—some or all of which maybe displayed at the same or different time on display 122. In certainembodiments the displayed information is user-selectable so that a usercan customize the information shown on a given display screen. Display122 may include but is not limited to graphical display 138, forexample, providing a graphical output of glucose values over a monitoredtime period (which may show important markers such as meals, exercise,sleep, heart rate, blood pressure, etc.), numerical display 132, forexample, providing monitored glucose values (acquired or received inresponse to the request for the information), and trend or directionalarrow display 131 that indicates a rate of analyte change and/or a rateof the rate of analyte change, e.g., by moving locations on display 122.

As further shown in FIG. 1, display 122 may also include date display135 providing for example, date information for the user, time of dayinformation display 139 providing time of day information to the user,battery level indicator display 133 which graphically shows thecondition of the battery (rechargeable or disposable) of the displaydevice 120, sensor calibration status icon display 134 for example, inmonitoring systems that require periodic, routine or a predeterminednumber of user calibration events, notifying the user that the analytesensor calibration is necessary, audio/vibratory settings icon display136 for displaying the status of the audio/vibratory output or alarmstate, and wireless connectivity status icon display 137 that providesindication of wireless communication connection with other devices suchas on body electronics, data processing module 160, and/or remoteterminal 170. As additionally shown in FIG. 1, display 122 may furtherinclude simulated touch screen button 125, 126 for accessing menus,changing display graph output configurations or otherwise forcontrolling the operation of display device 120.

Referring back to FIG. 1, in certain embodiments, display 122 of displaydevice 120 may be additionally, or instead of visual display, configuredto output alarms notifications such as alarm and/or alert notifications,glucose values etc, which may be audible, tactile, or any combinationthereof. In one aspect, the display device 120 may include other outputcomponents such as a speaker, vibratory output component and the like toprovide audible and/or vibratory output indication to the user inaddition to the visual output indication provided on display 122.Further details and other display embodiments can be found in, e.g.,U.S. patent application Ser. No. 12/871,901, now U.S. Pat. No.8,514,086, U.S. provisional application Nos. 61/238,672, 61/247,541,61/297,625, the disclosures of each of which are incorporated herein byreference for all purposes.

After the positioning of on body electronics 110 on the skin surface andanalyte sensor 101 in vivo to establish fluid contact with ISF (or otherappropriate body fluid), on body electronics 110 in certain embodimentsis configured to wirelessly communicate analyte related data (such as,for example, data corresponding to monitored analyte level and/ormonitored temperature data, and/or stored historical analyte relateddata) when on body electronics 110 receives a command or request signalfrom display device 120. In certain embodiments, on body electronics 110may be configured to at least periodically broadcast real time dataassociated with monitored analyte level which is received by displaydevice 120 when display device 120 is within communication range of thedata broadcast from on body electronics 110, i.e., it does not need acommand or request from a display device to send information.

For example, display device 120 may be configured to transmit one ormore commands to on body electronics 110 to initiate data transfer, andin response, on body electronics 110 may be configured to wirelesslytransmit stored analyte related data collected during the monitoringtime period to display device 120. Display device 120 may in turn beconnected to a remote terminal 170 such as a personal computer andfunctions as a data conduit to transfer the stored analyte levelinformation from the on body electronics 110 to remote terminal 170. Incertain embodiments, the received data from the on body electronics 110may be stored (permanently or temporarily) in one or more memory of thedisplay device 120. In certain other embodiments, display device 120 isconfigured as a data conduit to pass the data received from on bodyelectronics 110 to remote terminal 170 that is connected to displaydevice 120.

Referring still to FIG. 1, also shown in analyte monitoring system 100are data processing module 160 and remote terminal 170. Remote terminal170 may include a personal computer, a server terminal a laptop computeror other suitable data processing devices including software for datamanagement and analysis and communication with the components in theanalyte monitoring system 100. For example, remote terminal 170 may beconnected to a local area network (LAN), a wide area network (WAN), orother data network for uni-directional or bi-directional datacommunication between remote terminal 170 and display device 120 and/ordata processing module 160.

Remote terminal 170 in certain embodiments may include one or morecomputer terminals located at a physician's office or a hospital. Forexample, remote terminal 170 may be located at a location other than thelocation of display device 120. Remote terminal 170 and display device120 could be in different rooms or different buildings. Remote terminal170 and display device 120 could be at least about one mile apart, e.g.,at least about 10 miles apart, e.g., at least about 100 miles apart. Forexample, remote terminal 170 could be in the same city as display device120, remote terminal 170 could be in a different city than displaydevice 120, remote terminal 170 could be in the same state as displaydevice 120, remote terminal 170 could be in a different state thandisplay device 120, remote terminal 170 could be in the same country asdisplay device 120, or remote terminal 170 could be in a differentcountry than display device 120, for example.

In certain embodiments, a separate, optional datacommunication/processing device such as data processing module 160 maybe provided in analyte monitoring system 100. Data processing module 160may include components to communicate using one or more wirelesscommunication protocols such as, for example, but not limited to,infrared (IR) protocol, Bluetooth® protocol, Zigbee® protocol, and802.11 wireless LAN protocol. Additional description of communicationprotocols including those based on Bluetooth® protocol and/or Zigbee®protocol can be found in U.S. Patent Publication No. 2006/0193375incorporated herein by reference for all purposes. Data processingmodule 160 may further include communication ports, drivers orconnectors to establish wired communication with one or more of displaydevice 120, on body electronics 110, or remote terminal 170 including,for example, but not limited to USB connector and/or USB port, Ethernetconnector and/or port, FireWire connector and/or port, or RS-232 portand/or connector.

In certain embodiments, data processing module 160 is programmed totransmit a polling or query signal to on body electronics 110 at apredetermined time interval (e.g., once every minute, once every fiveminutes, or the like), and in response, receive the monitored analytelevel information from on body electronics 110. Data processing module160 stores in its memory the received analyte level information, and/orrelays or retransmits the received information to another device such asdisplay device 120. More specifically in certain embodiments, dataprocessing module 160 may be configured as a data relay device toretransmit or pass through the received analyte level data from on bodyelectronics 110 to display device 120 or a remote terminal (for example,over a data network such as a cellular or WiFi data network) or both.

In certain embodiments, on body electronics 110 and data processingmodule 160 may be positioned on the skin surface of the user within apredetermined distance of each other (for example, about 1-12 inches, orabout 1-10 inches, or about 1-7 inches, or about 1-5 inches) such thatperiodic communication between on body electronics 110 and dataprocessing module 160 is maintained. Alternatively, data processingmodule 160 may be worn on a belt or clothing item of the user, such thatthe desired distance for communication between the on body electronics110 and data processing module 160 for data communication is maintained.In a further aspect, the housing of data processing module 160 may beconfigured to couple to or engage with on body electronics 110 such thatthe two devices are combined or integrated as a single assembly andpositioned on the skin surface. In further embodiments, data processingmodule 160 is detachably engaged or connected to on body electronics 110providing additional modularity such that data processing module 160 maybe optionally removed or reattached as desired.

Referring again to FIG. 1, in certain embodiments, data processingmodule 160 is programmed to transmit a command or signal to on bodyelectronics 110 at a predetermined time interval such as once everyminute, or once every 5 minutes or once every 30 minutes or any othersuitable or desired programmable time interval to request analyterelated data from on body electronics 110. When data processing module160 receives the requested analyte related data, it stores the receiveddata. In this manner, analyte monitoring system 100 may be configured toreceive the continuously monitored analyte related information at theprogrammed or programmable time interval, which is stored and/ordisplayed to the user. The stored data in data processing module 160 maybe subsequently provided or transmitted to display device 120, remoteterminal 170 or the like for subsequent data analysis such asidentifying frequency of periods of glycemic level excursions over themonitored time period, or the frequency of the alarm event occurrenceduring the monitored time period, for example, to improve therapyrelated decisions. Using this information, the doctor, healthcareprovider or the user may adjust or recommend modification to the diet,daily habits and routines such as exercise, and the like.

In another embodiment, data processing module 160 transmits a command orsignal to on body electronics 110 to receive the analyte related data inresponse to a user activation of a switch provided on data processingmodule 160 or a user initiated command received from display device 120.In further embodiments, data processing module 160 is configured totransmit a command or signal to on body electronics 110 in response toreceiving a user initiated command only after a predetermined timeinterval has elapsed. For example, in certain embodiments, if the userdoes not initiate communication within a programmed time period, suchas, for example about 5 hours from last communication (or 10 hours fromthe last communication, or 24 hours from the last communication), thedata processing module 160 may be programmed to automatically transmit arequest command or signal to on body electronics 110. Alternatively,data processing module 160 may be programmed to activate an alarm tonotify the user that a predetermined period of time has elapsed sincethe last communication between the data processing module 160 and onbody electronics 110. In this manner, users or healthcare providers mayprogram or configure data processing module 160 to provide certaincompliance with analyte monitoring regimen, so that frequentdetermination of analyte levels is maintained or performed by the user.

In certain embodiments, when a programmed or programmable alarmcondition is detected (for example, a detected glucose level monitoredby analyte sensor 101) that is outside a predetermined acceptable rangeindicating a physiological condition which requires attention orintervention for medical treatment or analysis (for example, ahypoglycemic condition, a hyperglycemic condition, an impendinghyperglycemic condition or an impending hypoglycemic condition), the oneor more output indications may be generated by the control logic orprocessor of the on body electronics 110 and output to the user on auser interface of on body electronics 110 so that corrective action maybe timely taken. In addition to or alternatively, if display device 120is within communication range, the output indications or alarm data maybe communicated to display device 120 whose processor, upon detection ofthe alarm data reception, controls the display 122 to output one or morenotification.

In certain embodiments, control logic or microprocessors of on bodyelectronics 110 include software programs to determine future oranticipated analyte levels based on information obtained from analytesensor 101, e.g., the current analyte level, the rate of change of theanalyte level, the acceleration of the analyte level change, and/oranalyte trend information determined based on stored monitored analytedata providing a historical trend or direction of analyte levelfluctuation as a function of time during monitored time period.Predictive alarm parameters may be programmed or programmable in displaydevice 120, or the on body electronics 110, or both, and output to theuser in advance of anticipating the user's analyte level reaching thefuture level. This provides the user an opportunity to take timelycorrective action.

Information, such as variation or fluctuation of the monitored analytelevel as a function of time over the monitored time period providinganalyte trend information, for example, may be determined by one or morecontrol logic or microprocessors of display device 120, data processingmodule 160, and/or remote terminal 170, and/or on body electronics 110.Such information may be displayed as, for example, a graph (such as aline graph) to indicate to the user the current and/or historical and/orand predicted future analyte levels as measured and predicted by theanalyte monitoring system 100. Such information may also be displayed asdirectional arrows (for example, see trend or directional arrow display131) or other icon(s), e.g., the position of which on the screenrelative to a reference point indicated whether the analyte level isincreasing or decreasing as well as the acceleration or deceleration ofthe increase or decrease in analyte level. This information may beutilized by the user to determine any necessary corrective actions toensure the analyte level remains within an acceptable and/or clinicallysafe range. Other visual indicators, including colors, flashing, fading,etc., as well as audio indicators including a change in pitch, volume,or tone of an audio output and/or vibratory or other tactile indicatorsmay also be incorporated into the display of trend data as means ofnotifying the user of the current level and/or direction and/or rate ofchange of the monitored analyte level. For example, based on adetermined rate of glucose change, programmed clinically significantglucose threshold levels (e.g., hyperglycemic and/or hypoglycemiclevels), and current analyte level derived by an in vivo analyte sensor,the system 100 may include an algorithm stored on computer readablemedium to determine the time it will take to reach a clinicallysignificant level and will output notification in advance of reachingthe clinically significant level, e.g., 30 minutes before a clinicallysignificant level is anticipated, and/or 20 minutes, and/or 10 minutes,and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and so on, withoutputs increasing in intensity or the like.

Referring again back to FIG. 1, in certain embodiments, softwarealgorithm(s) for execution by data processing module 160 may be storedin an external memory device such as an SD card, microSD card, compactflash card, XD card, Memory Stick card, Memory Stick Duo card, or USBmemory stick/device including executable programs stored in such devicesfor execution upon connection to the respective one or more of the onbody electronics 110, remote terminal 170 or display device 120. In afurther aspect, software algorithms for execution by data processingmodule 160 may be provided to a communication device such as a mobiletelephone including, for example, WiFi or Internet enabled smart phonesor personal digital assistants (PDAs) as a downloadable application forexecution by the downloading communication device.

Examples of smart phones include Windows®, Android™, iPhone® operatingsystem, Palm® WebOS™, Blackberry® operating system, or Symbian®operating system based mobile telephones with data network connectivityfunctionality for data communication over an internet connection and/ora local area network (LAN). PDAs as described above include, forexample, portable electronic devices including one or moremicroprocessors and data communication capability with a user interface(e.g., display/output unit and/or input unit, and configured forperforming data processing, data upload/download over the internet, forexample. In such embodiments, remote terminal 170 may be configured toprovide the executable application software to the one or more of thecommunication devices described above when communication between theremote terminal 170 and the devices are established.

In still further embodiments, executable software applications may beprovided over-the-air (OTA) as an OTA download such that wiredconnection to remote terminal 170 is not necessary. For example,executable applications may be automatically downloaded as softwaredownload to the communication device, and depending upon theconfiguration of the communication device, installed on the device foruse automatically, or based on user confirmation or acknowledgement onthe communication device to execute the installation of the application.The OTA download and installation of software may include softwareapplications and/or routines that are updates or upgrades to theexisting functions or features of data processing module 160 and/ordisplay device 120.

Referring back to remote terminal 170 of FIG. 1, in certain embodiments,new software and/or software updates such as software patches or fixes,firmware updates or software driver upgrades, among others, for displaydevice 120 and/or on body electronics 110 and/or data processing module160 may be provided by remote terminal 170 when communication betweenthe remote terminal 170 and display device 120 and/or data processingmodule 160 is established. For example, software upgrades, executableprogramming changes or modification for on body electronics 110 may bereceived from remote terminal 170 by one or more of display device 120or data processing module 160, and thereafter, provided to on bodyelectronics 110 to update its software or programmable functions. Forexample, in certain embodiments, software received and installed in onbody electronics 110 may include software bug fixes, modification to thepreviously stalled software parameters (modification to analyte relateddata storage time interval, resetting or adjusting time base orinformation of on body electronics 110, modification to the transmitteddata type, data transmission sequence, or data storage time period,among others). Additional details describing field upgradability ofsoftware of portable electronic devices, and data processing areprovided in U.S. application Ser. Nos. 12/698,124, 12/794,721, now U.S.Pat. No. 8,595,607, Ser. Nos. 12/699,653, and 12/699,844, now U.S. Pat.No. 8,930,203, and U.S. Provisional Application Nos. 61/359,265, and61/325,155 the disclosure of which is incorporated by reference hereinfor all purposes.

Embodiments of on-Body Electronics Units

FIGS. 2A-2B are perspective and top cross sectional views, respectively,of on body electronics 110 of FIG. 1 in certain embodiments. Inparticular, FIG. 2A illustrates the cross-sectional view of on bodyelectronics 110 along the dotted line A shown in FIG. 2B. Referring toFIGS. 2A-2B, on body electronics 110 in certain embodiments is sized andshaped such that the height or thickness profile is minimized (forexample, to less than or equal to about 10 mm, e.g., or less than orequal to about 7 mm, e.g., or less than or equal to about 5 mm, e.g., orless than or equal to about 4.5 mm, e.g., or less than or equal to about4 mm or less). For example, as shown in the figures, in certainembodiments, on body electronics 110 includes a dome-like or taperedshape with a height or thickness dimension of up to about 5 mm at itsthickest point, and may taper (gradually or step wise) to a height orthickness dimension of less than about 4 mm, or about 3 mm or less, orabout 2 mm or less, or about 1 mm or less. In certain embodiments, onbody electronics 110 has a compact z-height 118 (e.g., height orthickness of on body electronics 110) that is not more than about 4.5 mmthick at its thickest area (if the thickness is not uniform or rathervaries within a given unit), and no more than about 4.6 mm thickincluding an adhesive patch.

Referring to FIGS. 2A-2B, in certain embodiments, analyte sensor 101 isassembled during manufacturing with on body electronics 110, forexample, and fixedly connected to PCB 111 of on body electronics 110. Asshown in FIGS. 2A-2B, proximal portion 102 of sensor 101 is placed onupper surface 112 of PCB 111 and secured to PCB 111 for example, usingrivets, fasteners, clamps or the like. The fixedly positioned proximalportion 102 of sensor 101 may be positioned such that proximal portion102 is electrically coupled to the respective contact points on uppersurface 112 of PCB 111. As can be further seen from FIGS. 2A-2B, in suchembodiments, the distal portion 103 of sensor 101 is bent or angled suchthat approximately a 90 degree angle is defined between the proximalportion 102 and distal portion 103 of sensor 101. In certainembodiments, the angle between the proximal portion 102 and distalportion 103 of sensor 101 may be less than about 90 degrees, less thanabout 80 degrees, less than about 70 degrees, less than about 60degrees, less than about 50 degrees, less than about 40 degrees, lessthan about 30 degrees, less than about 20 degrees, or less than about 10degrees.

Referring still to FIG. 2A-2B, as shown, sensor 101 is positionedrelative to PCB 111 such that sensor 101 is positioned through opening109 defined between upper surface 112 and lower surface 113 of PCB 111.In certain embodiments, PCBs of on body electronics do not include anopening such as that shown in FIGS. 2A-2B.

Furthermore, adhesive layer 140 (single sided or two sided) may beprovided to securely position on body electronics 110 on the skinsurface during and after sensor deployment. Adhesive may be manufacturedso to be attached to the on body unit, or to be attachable postmanufacturing, e.g., by a user. In certain embodiments, a sensorinsertion process causes the adhesive patch to be attached to the onbody unit. In certain embodiments, on body electronics 110 with analytesensor 101 may be contained or disposed (e.g., during manufacturing)within insertion device 150 (FIG. 1), avoiding the need for a user toalign, position, or otherwise connect or couple analyte sensor 101 andon body electronics 110 to insertion device 150 (FIG. 1) prior to theinsertion of analyte sensor 101 and initializing on body electronics110. In certain embodiments, an optional sensor guide 105 is provided tofurther assist in alignment of the analyte sensor 101 with insertiondevice 150. Thus, potential misuse, user error, or misalignment ofanalyte sensor 101 relative to a needle or insertion mechanism ofinsertion device 150 by the user may be avoided.

Referring to FIGS. 2A-2B, embodiments of on body electronics 110 includedimensions and weight that are optimized for reduction and thusmaximized for comfort in use and wear. In certain embodiments, on bodyelectronics 110 has a small on-body footprint, e.g., less than about 50mm in diameter excluding adhesive patch 140 e.g., less than about 45 mmin diameter excluding adhesive patch 140, e.g., less than about 40 mm indiameter excluding adhesive patch 140, e.g., less than about 35 mm indiameter excluding adhesive patch 140, e.g., less than about 30 mm indiameter excluding adhesive patch 140, where in certain embodiments theon-body footprint may be about 25 mm to about 28 mm excluding adhesivepatch 140.

In certain embodiments, on body electronics 110, including adhesivepatch 140, has an on-body footprint that is less than about 70 mm indiameter (at its widest if it is not uniform), e.g., less than about 65mm in diameter, e.g., less than about 60 mm in diameter, e.g., less thanabout 55 mm in diameter, e.g., less than about 50 mm in diameter, e.g.,less than about 45 mm in diameter, e.g., less than about 40 mm indiameter, where in certain embodiments the on-body footprint may beabout 35 mm to about 37 mm including adhesive patch 140.

In certain embodiments, adhesive patch 140 has an on body footprint thatis less than about 3.0 inches in diameter, e.g., less than about 2.0inches in diameter, less than about 1.0 inches in diameter, where incertain embodiments an adhesive patch may have a diameter that is 1.0inch to about 1.5 inches or less.

Embodiments include on body electronics 110 that has a small surfacearea, e.g., less than about 2 square inches excluding adhesive patch140, e.g., less than about 1.5 square inches excluding adhesive patch140, e.g., less than about 1 square inches excluding adhesive patch 140,e.g., less than about 0.9 square inches excluding adhesive patch 140,e.g., less than about 0.8 square inches excluding adhesive patch 140,e.g., less than about 0.75 square inches excluding adhesive patch 140,e.g., less than about 0.7 square inches excluding adhesive patch 140,where in certain embodiments the surface area of an on body electronicsunit may be about 0.75 square inches to about 0.79 square inchesexcluding an adhesive patch.

In certain embodiments, on body electronics 110, including adhesivepatch 140, has a surface area that is about 3.0 square inches or lessincluding an adhesive patch, e.g., about 2.0 square inches or lessincluding an adhesive patch, e.g., about 1.9 square inches or lessincluding an adhesive patch, e.g., about 1.8 square inches or lessincluding an adhesive patch, e.g., about 1.75 square inches or lessincluding an adhesive patch, e.g., about 1.6 square inches or lessincluding an adhesive patch, where in certain embodiments the surfacearea of an on body electronics unit may be about 1.75 square inches toabout 1.77 square inches or less.

In certain embodiments, on body electronics 110 may have a circularfootprint and/or adhesive patch 140 may have a circular footprint. Incertain embodiments, on body electronics 110 may be circular in shape.Other shapes for on body electronics and/or adhesive patches include,but are not limited to oval, rectangle, square triangle, or polygonshapes may also be used, as well as irregular and complex shapes.

In certain embodiments, on body electronics 110 has low mass, e.g., lessthan about 10 grams including adhesive patch 140 e.g., less than about 5grams including adhesive patch 140, less than about 3.5 grams includingadhesive patch 140, wherein in certain embodiments the mass is no morethan 3 grams including adhesive patch 140.

FIG. 3 illustrates a PCB for use in on body electronics in certainembodiments. Referring to FIG. 3, PCB 300 in certain embodimentsincludes a plurality of notches 310 a-310 i around an outer periphery ofPCB 300. In certain embodiments, notches 310 a-310 i provide a flowpathduring manufacturing for an overmold material to encapsulate first andsecond surfaces 320, 330 of PCB 300 within a housing of an on bodyelectronics. Referring still to FIG. 3, in certain embodiments, notch340 is additionally provided on the outer periphery of PCB 300 toreceive and retain a battery 350. As shown, battery 350 in certainembodiments is securely retained within notch 340 of PCB 300 usingsecurement element 360 that is fixedly retained on first surface 320 ofPCB 300. In certain embodiments, securement element 360 is configured asbattery contact terminal to connect the battery to a respectiveelectrical contact on PCB 300 to provide power to the components of PCB300 in an on body electronics. In certain embodiments, PCB 300 may beencapsulated after all the components including battery 350 andsecurement element 360 are assembled.

Referring still to FIG. 3, in certain embodiments, an antenna 390 forwireless communication may include surface mounted inductors 391 a-391 jprovided between each of the plurality of notches 310 a-310 i and 340 ofPCB 300 either on a top and/or bottom surface of PCB 300, or at the edgesurface of PCB 300 within notches 310 a-310 i, similar to battery 350 innotch 340. In addition, in certain embodiments, surface mountedthermistors 370, 380 are provided on first and second surfaces 320, 330of PCB 300 to detect/monitor on skin temperature and ambienttemperature.

FIG. 4A illustrates a side view of on body electronics 400 in certainembodiments. Referring to FIG. 4A, on body electronics 400 includeshousing 410 with PCB 411 provided therein, PCB 411 having a portion inelectrical contact with analyte sensor 401 such that proximal portion402 of analyte sensor 401 is electrically connected to bottom surface411A of PCB 411 while distal portion 403 of analyte sensor 401 protrudesoutwards or downwards from bottom surface 410A of on body electronics400. Distal portion 403 of analyte sensor 401 is maintained in fluidcontact with, for example, ISF under the skin layer when on bodyelectronics 400 is positioned on the skin surface with analyte sensor401 transcutaneously positioned for analyte monitoring.

Referring to FIG. 4A, in certain embodiments, PCB 411 and the proximalportion 402 of analyte sensor 401 may be encapsulated either partiallyor entirely, with potting material. Encapsulation of PCB 411 andproximal portion 402 of analyte sensor 401 provides protection of theelectronic components provided on PCB 411 from contaminants and/ormoisture. In certain embodiments, PCB 411 includes a data processing orcontrol unit such as one or more microprocessors and/or ASICs, one ormore memory or data storage devices such as random access memory (RAM),read only memory (ROM) and the like, to store data and programmingand/or control logic or routines to perform the operations related tothe processing of signals received from analyte sensor 401. Dataprocessing or control unit may be programmed to perform signalprocessing such as, for example, but not limited to, analog to digitalconversion, signal filtering, storage, data transmission and reception.

Referring still to FIG. 4A, in certain embodiments, analyte sensor 401is permanently connected to PCB 411, such that the respective electricalcontacts of the sensor including electrical contacts for one or more ofthe electrodes including, for example, a working electrode, a counterelectrode, a reference or a counter/reference electrode, in a threeelectrode system are permanently maintained in electrical communicationwith respective electrical contacts on PCB 411. In other words, duringmanufacturing and assembly, analyte sensor 401 and PCB 411 arepermanently connected together to provide a fixed electrical coupling.In this manner, in certain embodiments, on body electronics 400 isdisabled, deactivated or no longer used after the expiration of thesensor useful life.

FIG. 4B illustrates a side view of PCB 411 in contact with analytesensor 401 in certain embodiments with housing 400 removed. Referring toFIG. 4B, analyte sensor 401 is physically attached to PCB 411 withoutany substantial or significant stress or pressure upon the body ofanalyte sensor 401 to either bend or otherwise deform the shape ofanalyte sensor 401 in order to connect the electrodes of analyte sensor401 to respective electrical contacts on PCB 411 (however, the sensorcould be bent if desired, for example, to further minimize the height ofthe on body electronics assembly). That is, as discussed further inconjunction with FIG. 5 below, sensor 401 may be connected to PCB 411using an interconnect component that provides electrical connection orcoupling between analyte sensor 401 and PCB 411 without deforming orotherwise bending of flexing the body of analyte sensor 401 in order tomake the electrical connection.

FIG. 5 is a perspective, exploded view of the components of PCB 411 incontact with the analyte sensor 401 shown in FIG. 4B in certainembodiments. Referring to FIG. 5, proximal portion 402 of analyte sensor401 is connected to PCB 411 using a conductive film 530 and aninterconnect component 510 that includes conductive material 520. Thatis, in certain embodiments, conductive film 530 is positioned betweenthe proximal portion 402 of analyte sensor 401 and interconnectcomponent 510 such that when analyte sensor 401, conductive film 530 andinterconnect component 510 are physically attached, the electricalconnection of each of the electrodes of the analyte sensor 401 ismaintained via the conductive film 530 and interconnect component 510 toPCB 411.

In certain embodiments, conductive film 530 includes conductive tracesor contact points that electrically couple with respective electricalcontacts on the proximal portion 402 of analyte sensor 401 to provide acontinuous electrical signal path for electrodes of the analyte sensor401. Furthermore, as shown in FIG. 5, conductive film 530 in certainembodiments may be configured to provide electrical conductivity to atleast two (e.g., opposing) surfaces of its body such that when the twosurfaces of the conductive film 530 are physically coupled to theinterconnect component 510, the continuous electrical signal path foreach of the electrodes of the analyte sensor 401 is maintained via theinterconnect component 510 to PCB 411.

Referring still to FIG. 5, in certain embodiments, the interconnectcomponent 510 may include a three-sided or more configuration, e.g., asubstantially triangular shape or the like. For example, a triangularlyshaped interconnect may have a first surface in contact with therespective surface of the conductive film 530, while a second surface ofthe interconnect component 510 configured for electrical contact withthe electrical contact points on PCB 411 is substantially at a rightangle relative to the first surface of the interconnect component 510.The defined angular relationship between the first and second surfacesrespectively coupling to conductive film 530 and the contact points onPCB 411 substantially define the transcutaneous insertion angle of theanalyte sensor 401 relative to PCB 411 of on body electronics 400 (FIG.4). In certain embodiments, this geometry of interconnect component 510facilitates the electrical connection between the electrodes of theanalyte sensor 401 and the respective electrical contact points on PCB411 without physically modifying the configuration of either the analytesensor 401 or PCB 411. Of course, other geometries could be employed aswell. For example, different geometries (e.g., based on angularrelationships between a first and second surface) of interconnectcomponent 510 provides varied insertion angle of analyte sensor 101 suchas, for example, about 90 degrees or less, e.g., about 80 degrees orless, about 70 degrees or less, about 60 degrees or less, about 50degrees or less, about 40 degrees or less, about 30 degrees or less, orabout 20 degrees or less, relative to the skin surface.

In certain embodiments, conductive film 530 includes an anisotropicconductive film while the interconnect component 510 includes moldedcomponents which, in combination provide for a reduced height orz-profile 420 of the on body electronics 400 resulting from, forexample, the geometry of the interconnect component 510 that provides aplanar surface for connection or coupling with analyte sensor 401 andanother planar surface for connection to PCB 411. Embodiments alsoinclude conductive film 530 that is isotropic, or die cut. In thismanner, in certain embodiments, the configuration of the interconnectcomponent 510 provides mechanical fixturing and electrical connection ofanalyte sensor 401 to PCB 411 of on body electronics 400.

FIG. 6 is a close up detailed perspective view of analyte sensor 401,conductive film 530 and the interconnect component 510 shown in FIG. 5in certain embodiments. FIG. 7A is a bottom perspective view of theinterconnect component 510 shown in FIG. 6 while FIG. 7B is a topperspective view of the interconnect component 510 shown in FIG. 6 incertain embodiments. As can be seen from the figures, analyte sensor401, conductive film 530 and interconnect component 510 in certainembodiments are sized and shaped to be mated or physically coupled toeach other with the conductive film 530 disposed between the respectivesurfaces of the analyte sensor 401 proximal portion 402 and the firstcontacting surface of the interconnect component 510.

In this manner, electrical contacts 520 of interconnect component 510are maintained in signal communication with the respective electrodes ofanalyte sensor 401 via the conductive film 530 (and to the respectivecontact points on the printed circuit board (PCB) 411 of on bodyelectronics 400) such that when ready to use, on body device electronics400 includes PCB 411 connected to analyte sensor 401 in a fixed positionrelative to each other. Further, as discussed, PCB 411 may be fully orpartially encapsulated with potting material such as epoxy, polyurethaneor other suitable material or compounds to, for example, protect thecomponents of on body electronics 400 from contaminants or moisture.

In certain embodiments, the conductive film 530 may include anisotropicconductive adhesive film, e.g., such as those available from 3MCorporation, St. Paul, Minn., which is heat bondable, electricallyconductive and include a thermosetting epoxy/acrylate adhesive matrixwith conductive particles that allow interconnection of circuit linesthrough the adhesive thickness after bonding while providing sufficientspace or gap for electrical insulation in the plane of the adhesive.

Furthermore, referring back to FIGS. 5-7B, the interconnect component510 in certain embodiments may be manufactured using one or moreprocesses of injection molding, laser activation and/or metallization toprovide electrical conductive paths (for example, as shown on thesurfaces of the interconnect component 510), or assembly procedure toform the desired three dimensional triangular shape with two conductivesurfaces at substantially a 90 degree angle relative to each other asshown, for example, in FIGS. 5-7B. In certain embodiments, the twoconductive surfaces may be formed at an angle greater or less than 90degrees relative to each other.

Additionally, in certain embodiments, interconnect component 530 may beconfigured to be used as a spacer component for a temperature probe (forexample, thermistor, a thermocouple, or a resistive thermal device (RTD,or sometimes referred to as resistance temperature detectors)) thatdetects or monitors the temperature of or around or surrounding analytesensor 401. In certain embodiments, monitored or detected temperaturedata may be used to process the signals from analyte sensor 401 to, forexample, compensate for potential analyte sensor signal deviation (thusresulting in error) due to temperature change or variation.

Accordingly, in certain embodiments, analyte sensor 401 includingsensing chemistry, an analyte flux-limiting membrane and/or othercompositions, may be initially manufactured separately from the printedcircuit board (PCB) 411 and other components of on body electronics 400,and electrically connected during the final stages of the manufacturingprocess to electrically connect the electrodes of the analyte sensor 401to the respective electrical contact points on PCB 411. Use ofinterconnect component 510 in certain embodiments allows for the initialseparate manufacturing of analyte sensor 401 and on body electronics400, and thereafter, assembled or connected together to form anintegrated assembly prior to use.

In certain embodiments, the conductive material for the interconnectcomponent 510 includes conductive traces embedded in a flexiblematerial, such as a flexible strip, which generally can be formed from athermoplastic material. Suitable thermoplastic materials may includepolyimides such as for example, Kapton polyimide film, but othersuitable material may be used. In other embodiments, conductive tracesare encapsulated in a flexible sheath.

FIGS. 8A-8D illustrate on body electronics including a moduleinterconnect in certain embodiments, with FIGS. 8A-8B illustrating topperspective views, while FIGS. 8C-8D illustrate bottom perspectiveviews. Referring to FIGS. 8A-8D, on body electronics 810 includesmodular sensor assembly 802 which includes analyte sensor 801 (see e.g.,FIGS. 8C-8D), for engageably coupling with electronics component 806. Asillustrated, the modular sensor assembly 802 may be configured tointerlock or otherwise engage with the electronics component 806.Accordingly, upon engagement of modular sensor assembly 802 andelectronics component 806, on body electronics 810 with analyte sensor801 may be provided.

In certain embodiments, modular sensor assembly 802 may be a moldeddevice, such as for example, formed by injection molding techniques. Asillustrated in FIG. 8B, modular sensor assembly 802 includes bottomsurface 805 connected to top surface 807 by sidewall 803. As can be seenin the perspective views of FIGS. 8C and 8D, in certain embodiments, topsurface 807 includes conductive material 814 disposed thereon. Further,top surface 807 may include a vertical surface extending downwardly,which may include conductive material 816 disposed thereon. In certainembodiments, conductive material 816 includes conductive traces and/orconductive contacts.

Still referring to the figures, on body electronics 810 in certainembodiments include modular sensor assembly 802 and electronicscomponent 806 configured for a slidable engagement. As illustrated inFIG. 8B, the bottom of electronics component 806 may include a surfaceconfigured to slidably receive modular sensor assembly 802. Further, incertain embodiments, top surface 807 of modular sensor assembly 802 maybe configured to define a tongue to interlock with a correspondinggroove 804 defined in electronics component 806 to define the shape ofon body electronics 810.

Electronics component 806 in certain embodiments may include one or morePCBs including conductive material 808 disposed thereon, such as one ormore conductive traces and/or conductive contacts. During engagement ofelectronics component 806 with modular sensor assembly 802, theconductive material 808 can interface with interconnect conductivematerial 814. Thus, during engagement, the electronics component 806 andmodular sensor assembly 802 establishes electrical communication.

As illustrated in FIG. 8C, modular sensor assembly 802 includes analytesensor 801 secured or otherwise coupled to a surface of the modularsensor assembly 802. For example, analyte sensor 801 may be coupled tothe vertical surface extending from the top surface of the modularsensor assembly 802. In this manner, the vertical surface includesconductive material, such as conductive contacts 816 that connect withthe one or more conductive contacts of analyte sensor 801 to establishan electrical communication between analyte sensor 801 and modularsensor assembly 802.

In certain embodiments, as best illustrated in FIGS. 8C and 8D, analytesensor 801 may be mounted to sidewall 803 of modular sensor assembly802. In this embodiment, distal portion 801 a of analyte sensor 801 isinserted perpendicular to the skin (not shown). In this regard, thebottom surface of the modular sensor assembly 802 includes an aperture820 (FIGS. 8C and 8D) to permit the distal portion 801 a of analytesensor 801 to extend from the bottom of on body electronics 810 suchthat distal portion 801 a of analyte sensor 801 may be implanted intothe body of a user when in use. In certain embodiments, modular sensorassembly 802 may also include a power source 812, such as a battery.Power source 812 may provide power via conductive traces 814 to theelectronics component 806. In this manner, the electronics component 806may be powered by power source 812 of modular sensor assembly 802 suchthat the electronics component 806 does not need an internal powersource.

The conductive material disposed on the modular sensor assembly 802and/or the electronics component 806 and analyte sensor 801 may includeconductive film, such as but not limited to, an anisotropic film.Conductive material, such as the conductive film and/or the Zebra styleconnector, can provide both a mechanical and electrical connectionbetween modular sensor assembly 802 and sensor 801 or electronicscomponent 806. Modular sensor assembly 802, analyte sensor 801, andelectronics component 806 may also be bonded together utilizing anadhesive, such as a UV curable adhesive, or a multi-adhesive, such as asilver loaded epoxy can be used. Other adhesives can alternatively beemployed.

FIGS. 9A-9J illustrate on body electronics including an analyte sensorand the PCB provided in the housing of the on body electronics incertain embodiments. Referring to the Figures, in certain embodiments,the analyte sensor 901 is electrically connected to the printed circuitboard 911 during manufacturing of the on body patch assembly such thatthe position of the analyte sensor 901 is fixed relative to the printedcircuit board 911 prior to and during use. For example, referring toFIGS. 9A and 9B, as shown, the analyte sensor 901 is electricallyconnected to the printed circuit board 911 such that the respectivecontact pads 904 on the analyte sensor 901 are soldered, jet bonded, orotherwise electrically connected to the respective one of the contactpoints 960 on the printed circuit board 911. In certain embodiments,printed circuit board 911 may include a hole 915 for guiding and/oraligning insertion needle assembly 930 (FIG. 9E) and the sensor distalportion 903.

In certain embodiments, as shown in FIG. 9C, conductive material 950such as solder, gold, silver, silver filled epoxy, copper or othersuitable material is separately provided on each of the contact pads 904of analyte sensor 901 so as to establish electrical connection with therespective contact points 960 on PCB 911. A side cross sectional view ofsuch connection is shown in FIGS. 9C and 9D where the analyte sensor 901is permanently connected to PCB 911, for example, at a substantially 90degree angle relative to PCB 911 or at other suitable angles. In FIGS.9C-9D, it can be seen that wetted solder or conductive adhesive 950 isprovided to establish permanent electrical connection between thecontact pads 904 of the analyte sensor 901 and the respective contactpoints 960 on the printed circuit board 911. More specifically, FIG. 9Dshows conductive material 950 after it has been applied and integratedwith the contact point 960 on PCB 911, while FIG. 9C shows conductivematerial 950 applied on the contact point 960 on PCB 911 before it isintegrated with it to form the electrical connection.

Referring still to the Figures, while the connection between analytesensor 901 and PCB 911 is shown and described as a 90 degree angle, incertain embodiments, the relative angle between the sensor 901 andprinted circuit board 911 may vary and include one or more angles lessthan 90 degrees relative to each other, such as about 80 degrees orless, about 70 degrees or less, about 60 degrees or less, about 50degrees or less, about 45 degrees or less, about 40 degrees or less,about 30 degrees or less, or about 20 degrees or less. Furthermore, incertain embodiments, the attachment or connection of the analyte sensor901 to the printed circuit board 911 may include conductive adhesivebonding, gold ball bonding, silver ball bonding, solder jet bonding, orother suitable equivalent bonding techniques.

Referring to FIGS. 9E-9I, certain embodiments include a mounting bracket910 for retaining analyte sensor 901 in position relative to PCB 911during manufacturing and/or use. More specifically, in certainembodiments, mounting bracket 910 includes a guide or a hole 905 foralignment of insertion needle 930 and distal portion 903 of analytesensor 901 coupled with insertion needle 930 prior to and during theinsertion of analyte sensor 901. Mounting bracket 910 may be further beconfigured to retain or assist in the withdrawal of insertion needle 930after transcutaneous placement of analyte sensor 901 distal portion 903.As shown, FIGS. 9G-9I illustrate a top planar view, a side planar viewand a bottom planar view, respectively, of mounting bracket 910 incertain embodiments. Also shown is guide or hole 905 in mounting bracket910 discussed above for guiding and/or aligning insertion needle 930 andsensor distal portion 903.

Referring back to the Figures, FIG. 9E illustrates a component view ofinsertion needle 930, mounting bracket 910, analyte sensor 901, and PCB911, while FIG. 9F illustrates an assembled view of insertion needle930, mounting bracket 910, analyte sensor 901, and PCB 911. In certainembodiments, insertion needle 930 includes an opening along alongitudinal side for disengaging with analyte sensor 901 when on bodyelectronics 902 is placed on the skin surface, with distal portion 903of analyte sensor 901 positioned under the skin surface in fluid contactwith ISF. Again, guide or hole 905 of mounting bracket 910 in certainembodiments guides or assists the withdrawal or retraction of insertionneedle 930 after transcutaneous sensor placement. In certainembodiments, mounting bracket 910 may be fabricated using injectionmolding process or other suitable processes.

Referring still to the Figures, in certain embodiments, optionalfeatures such as support 990 for positioning and maintaining analytesensor 901 in the desired orientation or position relative to PCB 911during on body electronics assembly is shown in FIG. 9J. Also shown inFIG. 9J is insertion needle guide 980 having distal portion 903 ofanalyte sensor 901 provided therethrough. Support 990 may includeadditional protrusions, dimples or accents on its side facing the topsurface of the PCB 911 to assist and/or guide the orientation of analytesensor 901 during assembly of on body electronics 902.

In this manner, in certain embodiments, analyte sensor 901 may bepermanently connected to PCB 911 of on body electronics such that theformed integrated assembly is used and discarded together based on theuse of the analyte sensor.

FIGS. 10A and 10B illustrate a top planar view and a cross sectionalview, respectively, of an antenna and electronic circuit layout of theon body electronics for use in the analyte monitoring system 100 of FIG.1 in certain embodiments. More particularly, FIG. 10B is a crosssectional view along the dotted line B shown in FIG. 10A in certainembodiments. Referring to FIGS. 10A and 10B, antenna 1010 in certainembodiments includes a conductive material 1001, such as a PCB coppertrace or the like, provided on a substrate 1002, and further, aplurality of inductors 1003 a-1003 e disposed on the substrate 1002 andelectrically connected to the conductive layer 1001 in a loopconfiguration. In certain embodiments, inductors 1003 a-1003 e arespaced equidistantly from each other in the loop configuration.

In this embodiment, the loop is positioned substantially near theperimeter of the substrate, e.g., within about 50 mm or less, e.g.,within about 40 mm or less, within about 30 mm or less, within about 20mm or less, within about 10 mm or less, within about 5 mm or less,within about 3 mm or less, within about 1 mm or less. The looping and/orperimeter positioning further increases the area (or length) of theantenna, thereby increasing the transmission range of the antenna, forexample. In certain embodiments, some or all of the inductors 1003a-1003 e may not be spaced apart equidistant from each other. Also shownin FIGS. 10A and 10B is ASIC and/or microprocessor 1004 in electricalcommunication with the conductive layer 1001 for processing signals froman in vivo analyte sensor (not shown) and interfacing with the sensor inaddition to processing the commands or signals from display device 120(FIG. 1) and generating and/or providing the response data packet todisplay device 120.

FIG. 11 illustrates a top planar view of an antenna layout on thecircuit board of on body electronics in certain alternate embodiments.Referring to FIG. 11, compared to antenna 1010 of FIGS. 10A and 10B,antenna 1110 of the on body electronics shown in FIG. 11 may be providedaround only a portion or section of the outer periphery of PCB 1102, andradially wound substantially around the portion or section of the outerperiphery of PCB 1102. For example, as shown in FIG. 11, the conductivetrace forming the antenna 1110 may be provided in a looped, threadedmanner such that the continuous trace is alternatingly provided on thetop and the bottom surfaces of PCB 1102 along the portion of its outeredge or periphery, and/or threaded through the PCB 1102 repeatedly witheach loop about the periphery of PCB 1102. In certain embodiments, suchlooping back and forth between the top and bottom surfaces of PCB 1102may be about most or all of the perimeter of PCB 1102.

In certain embodiments, antenna 1110 shown in FIG. 11 provides for lowermanufacturing cost by reducing the antenna components and importantlymay require less space on PCB 1102 which further enables miniaturizationof an on body electronics unit. For example, configuration of antenna1110 in the embodiment shown in FIG. 11 obviates the need for separateinductors as compared to the antenna configuration shown in FIGS. 10Aand 10B. As such, the diameter of the overall PCB 1102 may be reduced byabout 10% or more, about 15% or more, about 20% or more, about 25% ormore, or about 30% or more. Also shown in FIG. 11 is microprocessorand/or ASIC 1104, in electrical communication with the antenna 1110 forprocessing signals from an in vivo analyte sensor (not shown) andinterfacing with the sensor in addition to processing the commands orsignals from display device 120 (FIG. 1) and generating and/or providingthe response data packet to display device 120.

In the manner described above and shown in conjunction with FIGS.10A-10B and 11, in certain embodiments, on body electronics antenna1010, 1110 may be printed as an internal conductive layer of PCBsurrounded by the ground plane on the top and bottom layers of PCB. Thatis, in one aspect, the top and bottom conductive layers may be separatedby layers of one or more dielectrics and a conductive layer with a loopantenna disposed therebetween as shown in FIG. 11. Alternatively,antenna for on body electronics may be printed on the top substrate 1002in series with a plurality of inductors 1003 a-1003 e as shown in FIGS.10A and 10B. In certain embodiments of antenna with inductors, thenumber of inductors may range from about 2 to about 10, for example,about 3 to about 7, or about 5 in some embodiments.

FIGS. 12A-12C illustrate an antenna configuration for on bodyelectronics 1210 in certain embodiments. In particular, FIG. 12Aillustrates an embodiment of on body electronics 1210 with adhesivelayer 1220 which includes an antenna 1230, FIG. 12B illustrates a crosssectional view of on body electronics 1210 and adhesive layer 1220 shownin FIG. 12A, and FIG. 12C illustrates an equivalent circuit diagram ofthe terminals and the capacitances from the antenna on the adhesivelayer of FIG. 12B.

Referring to FIG. 12A, embodiments include on body electronics 1210mounted to adhesive patch layer 1220 that includes an antenna 1230 onsurface 1221 of adhesive layer 1220. On body electronics 1210 in certainembodiments includes data control and logic implemented in ASIC 1211that is coupled to antenna 1212 for data communication. As shown in FIG.12A, antenna 1212 of on body electronics 1210 in certain embodiments mayinclude a loop antenna operatively coupled to ASIC 1211 on a PCB of theon body electronics 1210.

Referring back to FIG. 12A, antenna 1230 in certain embodiments includescopper, aluminum, or other suitable material, and may further include asingle, double or multiple loop antenna disposed around a periphery ofthe adhesive layer 1220. As further shown, antenna 1230 in certainembodiments includes two terminals 1231, 1232 which, in certainembodiments include capacitive terminals that may be formed of the samematerial as loop antenna 1230 such as copper or aluminum. As shown inFIG. 12A, terminals 1231, 1232 of antenna 1230 are positioned onadhesive layer 1220 such that the terminals 1231, 1232 do not contacteach other. Referring now to FIGS. 12A and 12B, on surface 1222 ofadhesive layer 1220, terminal 1233 is provided with dielectric layer1250 positioned between surface 1222 of adhesive layer 1220 and terminal1233. Terminal 1233, in certain embodiments, includes a capacitiveterminal that may be formed of the same material as terminals 1231,1232. In other embodiments, terminal 1233 may be formed of differentmaterial than material used to form terminals 1231, 1232.

Furthermore, as can be seen from the cross sectional view of FIG. 12B,terminal 1233 is sized and positioned on surface 1222 of adhesive layer1220 such that terminals 1231, 1232 are positioned on surface 1221 ofadhesive layer 1220 within a surface area of the adhesive layer 1220that includes the surface area on surface 1222 of the adhesive layerwhere terminal 1233 is positioned. In this manner, capacitance 1241 isformed between terminal 1231 and terminal 1233, and capacitance 1242 isformed between terminal 1231 and terminal 1233.

Referring again to FIG. 12B, in certain embodiments, dielectric layer1250 provided between terminal 1240 and surface 1222 of adhesive layer1220 includes material with relatively high dielectric constant (forexample, materials with dielectric constant of greater than about 90 ormore) increases capacitances 1241, 1242 generated between terminal 1231and terminal 1233, and between terminal 1222 and terminal 1233,respectively. In this manner, capacitances 1241, 1242 in certainembodiments are used to control the inductance to tune antenna 1230 onadhesive layer 1220 to the same frequency of the antenna 1212 of on bodyelectronics 1210. Tuning antenna 1230 to the same frequency as thefrequency of antenna 1212 extends the transmission range of on bodyelectronics 1210 for signal communication with display device and/orother components of the overall system 100 (FIG. 1). For example, bytuning antenna 1230 on adhesive layer 1220 to the frequency of antenna1212 of on body electronics 1210, the transmission range of on bodyelectronics 1210 for signal communication with display device 120(FIG. 1) or other components of the system 100 (FIG. 1) may be increasedby about 25%, about 50%, about 100%, about 150% or about 200% of thetransmission range using the antenna 1220 of on body electronics 1210only.

In the manner described, in certain embodiments, additional single ormultiple loop antenna disposed on an adhesive layer or other componentsseparate from the PCB of on skin electronics extends data transmissionrange for signal communication without requiring additional antennawithin the on skin electronics. Furthermore, capacitances 1241, 1242 incertain embodiments can be modified by using dielectric layer 1250 witha different dielectric constant provided between adhesive layer 1220 andterminal 1222. In other embodiments, dielectric layer 1250 may beoptional and not included between adhesive layer 1220 and terminal 1233to achieve the desired capacitance 1241, 1242.

FIG. 13 is an exemplary schematic of an on body electronics including anin vivo analyte sensor and sensor electronics component for use in theanalyte monitoring system 100 of FIG. 1 in certain embodiments. As shownin FIG. 13, on body electronics 1300 of the analyte monitoring system100, in certain embodiments includes a loop antenna 1320 fortransmitting the analyte related data to the display device 120 (orother component or device in the system 100 (FIG. 1)). Inductive powerloop antenna 1360 for processing the RF power from display device 120 isprovided, which in certain embodiments converts the RF power fromdisplay device 120 (FIG. 1) to corresponding DC power for the operationof the on body electronics 1300. In this manner, in certain embodiments,on body electronics 1300 may be configured to operate as a passive datacommunication component, adopting inductive coupling power without aseparate power supply or battery for data transmission.

Furthermore, on body electronics 1300 in certain embodiments does notrequire a mechanism to initialize the device to place it in itsoperational mode (turn on the device) nor to deactivate or turn off (orpower down) on body electronics 1300. That is, on body electronics 1300may be initialized and enters an active or operational mode when itdetects the RF power from a display device. After initialization, onbody electronics 1300, in certain embodiments, upon detection ofradiated RF power from a display device, data communication componentsof on body electronics 1300 enters an active communication mode totransmit and/or receive data packets or otherwise communication with adisplay device.

Referring back to FIG. 13, also provided is a plurality of supercapacitors C1, C2 coupled to inductive power loop antenna 1360 andcontroller 1310. Referring still to FIG. 13, controller 1310 may beprovided on a PCB assembly including the loop antenna 1320, thermistoris provided (not shown), analyte sensor contacts for coupling to theelectrodes of an analyte sensor, one or more storage devices such asnon-volatile memory (not shown), and other discrete components. Incertain aspects, the PCB assembly may be partially or fully encapsulatedwith, for example, potting material for protection from moisture and/orcontaminants.

FIG. 14A illustrates an embodiment of an input circuit for connectionbetween an in vivo analyte sensor and on body electronics. Referring toFIG. 14A, in certain embodiments, sensor 1401 may also function as anelectrolytic current source, and its output coupled with a resistor1402. Voltage developed across resistor 1402 can be measured, to providea value indicative of analyte concentration. In certain embodiments,while sensor 1401 may function as the electrolytic current source, andthus configured to generate a signal that is correlated with themonitored analyte level without a separate power supply, the on bodyelectronics coupled to sensor 1401 may include a power supply to providepower to operate the components of the on body electronics. For example,the power supply provided on the on body electronics may be used toprovide power to the microprocessor and/or ASIC of the on bodyelectronics to convert and/or filter and/or smooth and/or clip and/oraverage and/or correct and/or otherwise process the signals receivedfrom sensor 1401 and/or to store data associated with the signals fromsensor 1401.

In addition, capacitor 1403 may be provided in parallel or series withresistor 1402, such that the signal from analyte sensor 1401 may besmoothed. The instantaneous reading from the sensor assembly may providea time-averaged signal, or alternatively, a series of resistor-capacitorelements could be coupled to provide readings indicative of a timetrend. In such embodiments, separate power supply to power the sensor1401 is not necessary. In such embodiments, on body electronics 110 maynot include a separate power supply and rather, include a self-poweredsensor as described in further detail in U.S. patent application Ser.No. 12/393,921, 61/325,260, and 61/247,519 incorporated by referenceherein for all purposes.

In certain embodiments, passive electronic (analog) components may beused to generate average and/or trend data. For example, by adding acapacitor (such as capacitor 1403) in parallel to current-measuringresistor 1402, the resulting measured voltage signal is a smoothersignal than the original signal without the capacitor. Spikes,discontinuities and other rapid changes in the signal are removed orslowed down by the capacitor.

The averaging process in certain embodiments may generate a time shift(delay) in the measured signal, and circuits may be provided to deriveinformation related to the monitored analyte level from such delays.

One type of passive circuit that may be employed to generate signalsindicative of data trends over time comprises network of a plurality ofparallel resistor-capacitor pairs connected in series, wherein thecurrent provided by the analyte sensor is directed through the two endsof the network and the respective smoothed and time-shifted signalmeasurements are taken across each resistor-capacitor pair.

FIG. 14B illustrates such a network, comprising two resistor-capacitorpairs, resistor 1421 in parallel with capacitor 1422, and resistor 1423in parallel with capacitor 1424, with the two resistor-capacitor pairsconnected in a series connection between working electrode 1425 andcounter electrode 1426. Measurement points for voltages 1427 and 1428,indicative of analyte concentration, are disposed respectively acrosseach of the two parallel resistor-capacitor pairs. In this network, thetwo resistors 1421 and 1423 are both of approximately equal resistance,in this embodiment, approximately 5 Megaohms (the exact resistance ofthe resistors may not be critical, as long as it is sufficiently high tolimit current flow). In certain embodiments, resistance may bemaintained approximately equal between the resistors to equivalentlyscale the respective voltage measurements.

To achieve the desired delay, in certain embodiments, the capacitance ofcapacitor 1422 is greater than the capacitance of capacitor 1424. Inthis embodiment, the measured voltages 1427 and 1428, provide twoanalyte measurement signals with different time delays. If the signal isincreasing, the more averaged signal 1427 will be lower than the lessaveraged signal 1428. When the signal is decreasing the situation isreversed. This information is generated passively, powered by theelectricity generated by analyte sensor 1401 (FIG. 14A). In this mannerboth quantitative analyte measurements, and the measurement trend datacan be obtained.

FIG. 14C shows an electronic circuit in which sensor 1401 (FIG. 14A) hasa working electrode 1435, and two counter electrodes 1436 and 1437, withsignal current split between the two counter electrodes, in certainembodiments. Working electrode 1435 is connected to the circuit betweenthe respective resistor-capacitor parallel pairs resistor 1431 andcapacitor 1432, and resistor 1433 and capacitor 1434, and the counterelectrodes 1436 and 1437 are connected to the respective ends of thenetwork. Again, the resistors are each approximately 5 Megaohms andcapacitor 1432 has higher capacitance than capacitor 1434. In thismanner, two voltage signals 1439 and 1438 across capacitor 1432 andcapacitor 1434, respectively are generated, one signal with a largerdelay compared to the other. The capacitors 1432 and 1434 againdetermine the delays corresponding to the two arms of the circuit.

A higher resolution of the analyte level trend especially during periodswere the analyte level trend is changing (peaks and valleys) may beachieved by using a greater number of parallel resistor-capacitorelements in series and measuring the potential drop at each of theelements simultaneously. This is illustrated in FIG. 14D, which showsmeasurements taken across three series resistor-capacitor pairs betweenworking electrode 1447 and counter electrode 1448. In this embodiment,capacitor 1442 has higher capacitance than capacitor 1444, which hashigher capacitance than capacitor 1446, and the three resistors 1441,1443 and 1445, are of approximately equal resistance, of about 5megaohms. In this manner three voltage signals 1451, 1452, and 1453across capacitor 1442, capacitor 1444, and capacitor 1446, respectivelyare generated, each voltage signal 1451, 1452, 1453 with a differentdelay compared to each other. In certain embodiments, the size of thecapacitance of capacitors 1442, 1444, and 1446 determines the delayscorresponding to the arms of the circuit.

Referring now to FIG. 14E, shown is an alternative circuit to the onesdepicted in FIGS. 14B-14D. As shown, this circuit allows any value ofresistor-capacitor pair 1463/1464 to be chosen without any effect on thescale factor of the sensor with work electrode 1465 and counterelectrode 1466. In this embodiment, resistor 1463×capacitor 1464 isgreater than capacitor 1462×resistor 1461 and resistor 1461 isapproximately 5 Megaohms. The voltages 1467 and 1468 are referenced tothe transmitter signal ground and measure the un-lagged sensor output onvoltage 1467 and the time lagged output on voltage 1468. These twovoltages are measured by a circuit that has a very high input impedance.For example, it may be reasonable to achieve 10 Gigaohms input impedancein ASIC 1510 (FIG. 15). Consequently there may be no electrical“loading” effects on the signal. Any value of resistor 1463 may beselected allowing a small value of capacitor 1464 that is physicallysmaller and less expensive. Similar to the parallel resistor-capacitorcircuit described in FIG. 14D, additional time delayed signals may beobtained with the addition of more segments of resistors and capacitorssimilar to resistor-capacitor pair 1463/1464.

Delay and smoothing circuits such as those shown in FIGS. 14B-14E may beincorporated in an embodiment such as sensor assembly 1500 (FIG. 15) byproviding additional inputs to ASIC 1510 (FIG. 15) or correspondingelectronics. The signals provided may be selectively accessed throughthe ASIC for use in interfaced devices including on-demand devices,periodic reading devices, and data loggers, as required by the readingor logging application. The respective measurements can be appropriatelycoded into the RF transmission stream from sensor assembly 1500, anddecoded and used as needed for the functions performed by the particularinterfaced device.

If ASIC 1510 (FIG. 15) is part of the sensor, then ASIC 1510 can beprogrammed with a unique ID number. If ASIC 1510 is separate from thesensor, then it may be feasible to add a unique resistor to the sensorthat would allow identification of the sensor. For example, the resistorcould be a laser trimmed resistance in a range of values, with around 50different values. ASIC 1510 could be made to read that resistance sothat if a user attempted to re-use the same sensor the system softwarewould recognize a re-use occurrence.

FIG. 15 is a block diagram of the components of on body electronics incertain embodiments. More specifically, on body electronics 1500 incertain embodiments does not include a dedicated power supply and isconfigured to provide analyte concentration data in processed digitalformat. In such embodiments, the data processing functionality of onbody electronics 1500 may include analog to digital converter (ADC) 1521and digital signal processor (DSP) 1512. ADC 1521 and DSP 1512 may beintegrated with one or more oscillators 1514, modulator 1513, and RFamplifier 1515 for data communication to display device 120 (FIG. 1) orother data processing devices such as, for example, the data processingmodule 160 and/or remote terminal 170. In certain embodiments, thisintegration may be in the form of a monolithic integrated circuit, suchas an ASIC 1510.

In one embodiment, ASIC 1510 includes at least four terminals, includingat least two terminals 1505 a, 1505 b for the input from analyte sensor1501 and two terminals 1506 c, 1506 d for connection to antenna 1520(shown in FIG. 15 as a loop antenna), which may also serve as a powerinput for ASIC 1510. ASIC 1510 may also provide additional functions,such as data encryption, data compression, providing or communicating aserial number, time stamp and temperature readings, operating logic, andother functions, in addition to digitizing and transmitting data packetsand/or signals corresponding to measured analyte levels.

Antenna 1520 may be inductively coupled, including for example by RFcoupling in a manner similar to that used in passive RFID designs asdiscussed herein. Antenna 1520, when functioning as a passive RF orinductive pickup, may be configured to provide power to ASIC 1510, forexample, powering it long enough to take a sensor reading, digitizingit, and communicating the reading through the same antenna 1520, orotherwise for as long or short a period as may be required by theparticular application. While in many embodiments, battery-lessoperation of the sensor assembly will be an important feature, in otherembodiments a battery (including one or more cells) could be providedwithin on body electronics 1500 to supplement the power provided throughantenna 1520.

In certain embodiments, the on body electronics may include a powersupply such as a battery (for example, encapsulated with the electroniccomponents and/or the sensor with a suitable potting material within thehousing). The power supply in such embodiments is configured to providepower to the electronic components in the housing in addition toproviding power to the sensor. Furthermore, in certain embodiments, thepower supply of the on body electronics is not used or configured topower the data communication between the on body electronics with otherdevices of the analyte monitoring system.

FIG. 16 is a block diagram of the on body electronics in certainembodiments. Referring to FIG. 16, on body electronics 1600 in certainembodiments includes a control unit 1610 (such as, for example but notlimited to, one or more microprocessors, and/or ASICs), operativelycoupled to analog front end circuitry 1670 to process signals such asraw current signals received from analyte sensor 101. Also shown in FIG.16 is memory 1620 operatively coupled to control unit 1610 for storingdata and/or software routines for execution by control unit 1610. Memory1620 in certain embodiment may include electrically erasableprogrammable read only memory (EEPROM), erasable programmable read onlymemory (EPROM), random access memory (RAM), read only memory (ROM),flash memory, or one or more combinations thereof.

In certain embodiments, control unit 1610 accesses data or softwareroutines stored in the memory 1620 to update, store or replace storeddata or information in the memory 1620, in addition to retrieving one ormore stored software routines for execution. Also shown in FIG. 16 ispower supply 1660 which, in certain embodiments, provides power to someor all of the components of on body electronics 1600. For example, incertain embodiments, power supply 1660 is configured to provide power tothe components of on body electronics 1600 except for communicationmodule 1640. In such embodiments, on body electronics 1600 is configuredto operate analyte sensor 101 to detect and monitor the analyte level ata predetermined or programmed (or programmable) time intervals, andstoring, for example, the signals or data corresponding to the detectedanalyte levels.

In certain embodiments, power supply 1660 in on body electronics 1600may be toggled between its internal power source (e.g., a battery) andthe RF power received from display device 120. For example, in certainembodiments, on body electronics 1600 may include a diode or a switchthat is provided in the internal power source connection path in on bodyelectronics 1600 such that, when a predetermined level of RF power isdetected by on body electronics 1600, the diode or switch is triggeredto disable the internal power source connection (e.g., making an opencircuit at the power source connection path), and the components of onbody electronics is powered with the received RF power. The open circuitat the power source connection path prevents the internal power sourcefrom draining or dissipating as in the case when it is used to power onbody electronics 1600.

When the RF power from display device 120 falls below the predeterminedlevel, the diode or switch is triggered to establish the connectionbetween the internal power source and the other components of on bodyelectronics 1600 to power the on body electronics 1600 with the internalpower source. In this manner, in certain embodiments, toggling betweenthe internal power source and the RF power from display device 120 maybe configured to prolong or extend the useful life of the internal powersource.

The stored analyte related data, however, is not transmitted orotherwise communicated to another device such as display device 120(FIG. 1) until communication module 1640 is separately powered, forexample, with the RF power from display device 120 that is positionedwithin a predetermined distance from on body electronics 1600. In suchembodiments, analyte level is sampled based on the predetermined orprogrammed time intervals as discussed above, and stored in memory 1620.When analyte level information is requested, for example, based on arequest or transmit command received from another device such as displaydevice 120 (FIG. 1), using the RF power from the display device,communication module 1640 of on body electronics 1600 initiates datatransfer to the display device 120.

Referring back to FIG. 16, an optional output unit 1650 is provided toon body electronics 1600. In certain embodiments, output unit 1650 mayinclude an LED indicator, for example, to alert the user of one or morepredetermined conditions associated with the operation of the on bodyelectronics 1600 and/or the determined analyte level. For example, inone aspect, on body electronics 1600 may be programmed or configured toprovide a visual indication to notify the user of one or morepredetermined operational conditions of on body electronics 1600. Theone or more predetermined operational conditions may be configured bythe user or the healthcare provider, so that certain conditions areassociated with an output indication of on body electronics 1600.

By way of nonlimiting example, the on body electronics 1600 may beprogrammed to assert a notification using an LED indicator, or otherindicator on the on body electronics 1600 when signals (based on onesampled sensor data point, or multiple sensor data points) received fromanalyte sensor 101 are indicated to be beyond a programmed acceptablerange, potentially indicating a health risk condition such ashyperglycemia or hypoglycemia, or the onset or potential of suchconditions. With such prompt or indication, the user may be timelyinformed of such potential condition, and using display device 120,acquire the glucose level information from the on body electronics 1600to confirm the presence of such conditions so that timely correctiveactions may be taken.

As discussed, output unit 1650 of on body electronics 1600 mayoptionally include one or more output components such as a speaker, atactile indicator such as a vibration module, a visual indicator (forexample, an LED or OLED indicator), or the like to provide one or moreindications associated with its functions such as upon providing theanalyte related data to display device 120, alarm conditions associatedwith its internal components, detection of the RF power received fromthe display device 120, for example. By way of a non-limiting example,one or more exemplary output indication may include an audible sound(including for example, a short tone, a changing tone, multi-tone, oneor more programmed ringtones or one or more combinations thereof), avisual indication such as a blinking light of an LED or OLED indicator,a solid light on the LED or OLED indicator maintained at a predeterminedor programmed or programmable time period (for example, about 3 seconds,about 5 seconds, about 7 seconds, about 10 seconds or more), each ofwhich may be pre-programmed in the on body electronics 1600 and/orprogrammable by the user through the user interface of display device120 when in communication with on body electronics 1600.

For example, different levels of audible tones may be associated(programmed by the user, or pre-programmed in on body electronics 1600)with different conditions such that when asserted, each outputted tonemay be easily recognized by the user as an indication of the particularassociated condition. That is, the detected onset of hyperglycemiccondition based on the signal from the analyte sensor may be associatedwith a first predetermined loudness and/or tone, while the detectedonset of hypoglycemic condition based on the signal from the analytesensor 101 may be associated with a second predetermined loudness and/ortone. Alternatively, the programmed or programmable audible alerts mayinclude one or more sequence of audible outputs that are output based ona temporally spaced sequence or a sequence indicating an increase ordecrease in the level of loudness (using the same tone, or graduallyincreasing/decreasing tones).

Furthermore, in aspects of the present disclosure the audible outputindication may be asserted in conjunction with the visual outputindicator, simultaneously or alternating, as may be customized orprogrammable in the on body electronics 1600 or pre-programmed.

Referring again to FIG. 16, antenna 1630 and communication module 1640operatively coupled to the control unit 1610 may be configured to detectand process the RF power when on body electronics 1600 is positionedwithin predetermined proximity to the display device 120 (FIG. 1) thatis providing or radiating the RF power. Further, on body electronics1600 may provide analyte level information and optionally analyte trendor historical information based on stored analyte level data, to displaydevice 120. In certain aspects, the trend information may include aplurality of analyte level information over a predetermined time periodthat are stored in the memory 1620 of the on body electronics 1600 andprovided to the display device 120 with the real time analyte levelinformation. For example, the trend information may include a series oftime spaced analyte level data for the time period since the lasttransmission of the analyte level information to the display device 120.Alternatively, the trend information may include analyte level data forthe prior 30 minutes or one hour that are stored in memory 1620 andretrieved under the control of the control unit 1610 for transmission tothe display device 120.

In certain embodiments, on body electronics 1600 is configured to storeanalyte level data in first and second FIFO buffers that are part ofmemory 1620. The first FIFO buffer stores 16 (or 10 or 20) of the mostrecent analyte level data spaced one minute apart. The second FIFObuffer stores the most recent 8 hours (or 10 hours or 3 hours) ofanalyte level data spaced 10 minutes (or 15 minutes or 20 minutes). Thestored analyte level data are transmitted from on body electronics 1600to display unit 120 in response to a request received from display unit120. Display unit 120 uses the analyte level data from the first FIFObuffer to estimate glucose rate-of-change and analyte level data fromthe second FIFO buffer to determine historical plots or trendinformation.

In certain embodiments, for configurations of the on body electronicsthat includes a power supply, the on body electronics may be configuredto detect an RF control command (ping signal) from the display device120. More specifically, an On/Off Key (OOK) detector may be provided inthe on body electronics which is turned on and powered by the powersupply of the on body electronics to detect the RF control command orthe ping signal from the display device 120. Additional details of theOOK detector are provided in U.S. Patent Publication No. 2008/0278333,the disclosure of which is incorporated by reference for all purposes.In certain aspects, when the RF control command is detected, on bodyelectronics determines what response packet is necessary, and generatesthe response packet for transmission back to the display device 120. Inthis embodiment, the analyte sensor 101 continuously receives power fromthe power supply or the battery of the on body electronics and operatesto monitor the analyte level continuously in use. However, the sampledsignal from the analyte sensor 101 may not be provided to the displaydevice 120 until the on body electronics receives the RF power (from thedisplay device 120) to initiate the transmission of the data to thedisplay device 120. In one embodiment, the power supply of the on bodyelectronics may include a rechargeable battery which charges when the onbody electronics receives the RF power (from the display device 120, forexample).

Referring back to FIG. 1, in certain embodiments, on body electronics110 and the display device 120 may be configured to communicate usingRFID (radio frequency identification) protocols. More particularly, incertain embodiments, the display device 120 is configured to interrogatethe on body electronics 110 (associated with an RFID tag) over an RFcommunication link, and in response to the RF interrogation signal fromthe display device 120, on body electronics 110 provides an RF responsesignal including, for example, data associated with the sampled analytelevel from the sensor 101. Additional information regarding theoperation of RFID communication can be found in U.S. Pat. No. 7,545,272,and in U.S. application Ser. Nos. 12/698,124, 12/699,653, 12/761,387,now U.S. Pat. No. 8,497,777, and U.S. Patent Publication No.2009/0108992 the disclosure of which are incorporated herein byreference.

For example, in one embodiment, the display device 120 may include abackscatter RFID reader configured to provide an RF field such that whenon body electronics 110 is within the transmitted RF field of the RFIDreader, on body electronics 110 antenna is tuned and in turn provides areflected or response signal (for example, a backscatter signal) to thedisplay device 120. The reflected or response signal may include sampledanalyte level data from the analyte sensor 101.

In certain embodiments, when display device 120 is positioned in withina predetermined range of the on body electronics 110 and receives theresponse signal from the on body electronics 110, the display device 120is configured to output an indication (audible, visual or otherwise) toconfirm the analyte level measurement acquisition. That is, during thecourse of the 5 to 10 days of wearing the on body electronics 110, theuser may at any time position the display device 120 within apredetermined distance (for example, about 1-5 inches, or about 1-10inches, or about 1-12 inches) from on body electronics 110, and afterwaiting a few seconds of sample acquisition time period, an audibleindication is output confirming the receipt of the real time analytelevel information. The received analyte information may be output to thedisplay 122 (FIG. 1) of the display device 120 for presentation to theuser.

In some embodiments, a small linear induction generator, powered by bodymovement, may be built into on body electronics 120 of FIG. 1. Theinduction generator can serve to replace or supplement a battery, orother power source, or RF power configuration of on body electronics110. As schematically shown in FIG. 17, a generator may include magnet1701, which is movable relative to conductor 1702. Magnet 1701 may be astrong magnet, such as a rare earth magnet, and conductor 1702 may be asolenoid 1707 comprising a predetermined number of turns or winding ofcopper wire, within which magnet 1701 is axially slidable back and forthor up and down with respect to the solenoid windings. The movement ofthe magnet 1701 may be responsive to movement of the on body electronics110 (FIG. 1) as may occur during normal daily activity of the user withthe on body electronics 110 in place during use.

In certain embodiments, dimensions for the induction charging componentmay not be critical. The solenoid (tube) can be about 5 mm in diameterand 20 mm in length or smaller. Ranges for magnet sizes may range fromabout 3 mm in diameter and 3 mm in length, to micro sizes depending onthe distance available for travel and the amount of current and/orcharge desired. Wire diameter can be from about 0.003 mm to about 0.007mm. To cap the ends, a rubber stopper or snap on lid with a bumper canbe used. Alternatively, the cap features can be part of the transmittercasing.

Movement of magnet 1701 relative to conductor 1702 generateselectromotive forces (EMF) in conductor 1702 responsive to magnetic fluxchanges relative to the surface of conductor 1702. The EMF polarity mayfluctuate according to the direction in which the magnet 1701 is moving(although a single-polarity embodiment may be achieved where magnet 1701moves past conductor 1702 in one direction on a circular track). Incertain embodiments, such as linear embodiments with back-and-forthmagnet movement, in which electricity of changing polarity is generated,rectifier circuit 1703 (which may be a bridge rectifier) may beinterposed, and the output from the rectifier 1703 may be stored instorage unit 1708. An additional diode 1709 may be placed in thecharging circuit to prevent passive discharge through conductor 1702when the device is not actively charging. Storage device 1708 for theelectrical output of the generator may be a capacitor 1704 and/or diode1705, or alternately in a mechanical energy storage device such as aflywheel or a spring. Capacitor 1704 may be a supercapacitor, preferablyof high quality (high internal resistance, low leakage). Capacitor 1704(or other storage device) may be used as the sole power source for theon body device, or to supplement battery power. Used as a supplement toa battery, such a generator can extend battery life and/or permit theuse of high power consumption functions for the on body electronics 110(FIG. 1).

In certain embodiments, on body electronics 110 includes an ASIC thatincludes on chip a RISC (reduced instruction set computing) processor,an EEPROM, and a register (A/D converter operatively coupled to ananalyte sensor). EEPROM in certain embodiments includes a portion thathas programmed in it one or more characteristics or details associatedwith a memory management routine. Exemplary characteristics or detailsinclude, for example, a source address (e.g., whether it is an array ora single memory location), a destination address, a size/number of bytesto copy to memory, whether the memory location is a loop buffer (e.g.,overwriting the older stored values with new values when the end of thebuffer is reached).

In certain embodiments, a preset number of specific events may be finedand stored. For example, such events may include, but not limited to (1)RF power on event, (2) RF data read command; (3) RF data log command,(4) 1 minute data ready event (e.g., the A/D conversion of the signalfrom the analyte sensor is complete and the digitized data is ready forstorage), or (5) log data (10 minute analyte data) ready event (e.g.,when 10 minutes of analyte data is available for storage). For example,10 minutes of analyte data is available in certain embodiments when thelast A/D conversion for the 10 minute analyte data is complete. Incertain embodiments, other events or states may be defined.

In certain embodiments, when the RISC processor detects one of thespecific events, the RISC processor executes the programmed memorymanagement routine. During the execution of the memory managementroutine, the stored characteristics in EEPROM are retrieved. Based onthe retrieved characteristics, the memory management routine stores dataassociated with the detected event. For example, in certain embodiments,when a RF data log command event is detected, the data associated withthis event is logged in another section of the EEPROM on ASIC chip inaccordance with the retrieved characteristics (e.g., source anddestination address for the data associated with this event).

In certain embodiments, the characteristics stored in EEPROM associatedwith the specific events may be modified. For example, the source anddestination address may be changed or modified to point to a differentmemory device or storage unit of on body electronics 110 (e.g., aseparate EEPROM or memory that is not part of the ASIC chip). Forexample, data logger applications of the monitoring system 100 requiresstoring an amount of data (e.g., data for about 30 days, about 45 days,about 60 days or more, of 1 minute interval sampled analyte data (or 5minute interval sampled data, or 10 minute interval sampled data)) in onbody electronics 110 much greater than in on demand application where alimited amount of data is stored (e.g., 15 samples of 1 minute intervalsampled analyte data, and 6 hours of historical 10 minute intervalsampled analyte data). In certain embodiment, the amount of data forstorage in data logger application may exceed the capacity of on chipEEPROM. In such cases, a larger capacity, off chip EEPROM may beprovided in on body electronics 110 for storing data from the datalogger application. To configure on body electronics 110 to storesampled analyte data in the larger capacity, off chip EEPROM, in certainembodiments, the characteristics stored in EEPROM associated with theevents are reprogrammed or updated (for example, by updating the sourceand destination addresses associated with the events) so that datalogging or storage is pointed to the larger off chip EEPROM.

In this manner, by updating or reprogramming the portion of on chipEEPROM that stores the event characteristics, location of data storagein on body electronics 110 may be updated or modified depending upon thedesired application or use of on body electronics 110. Furthermore,other stored characteristics associated with one or more particularevents may be updated or reprogrammed in EEPROM as desired to modify theuse or application of on body electronics 110 in analyte monitoringsystem 100. This is further advantageously achieved withoutreprogramming or modifying the stored routines for executing theparticular events by the RISC processor.

Embodiments of on Body Electronics Initialization/Pairing

Prior to initialization of the on body electronics 110 (FIG. 1) for use,there may be a period of time post manufacturing during which on bodyelectronics 110 may be placed in sleep or idle mode. To initialize onbody electronics 110 to transition from the sleep or idle mode, incertain embodiments, a wireless signal may be provided to on bodyelectronics 110 which, upon receipt by on body electronics 110 initiatesan initialization routine to turn on body electronics 110 intooperational mode for example, by turning on its power source.

FIGS. 18A-18B illustrates a block diagram and circuit schematic,respectively of wireless turn on mechanism to initialize on bodyelectronics 110 (FIG. 1) in certain embodiments. Referring to FIGS. 16and 18A, in certain embodiments, communication module 1640 (FIG. 16)includes an electronic switching mechanism for turning on orinitializing on body electronics 110 (FIG. 1). More particularly, incertain embodiments, communication module 1640 (FIG. 16) includes acomplimentary MOSFET (metal oxide semiconductor field effect transistor)1810 arranged in combination with the battery or power supply 1870 andgate latching component 1830, which are connected to the load (or themain circuitry of the on body electronics 110 (FIG. 1). In certainembodiments, power supply 1870 may be a separate power supply, or thepower supply 1660 (FIG. 16) of on body electronics 110.

Referring back to FIG. 18A, also shown is antenna 1860 for receiving RFsignals. Antenna 1860 may be coupled to matching circuit 1850 and RFcarrier rectifier 1840 which is coupled to complimentary MOSFET 1810. Anexemplary equivalent circuit schematic for the wireless turn onmechanism shown in FIG. 18A is illustrated in FIG. 18B.

Referring to FIGS. 18A-18B, in certain embodiments, when an RF signal isreceived, for example, from display device 120 (FIG. 1) via the antenna1860, the received RF signal momentarily biases the gate of the Nchannel MOSFET M2 through diode D1 which rectifies the received RFsignal. Capacitor C1 and inductors L1 and L2 form the matching circuit1850 (FIG. 18A). Matching circuit 1850 is configured to match theimpedance between the antenna 1860 and diode D1. When the N-channelMOSFET M2 is biased, the drain pin of the P-channel MOSFET M1 is biased.When the N-channel MOSFET M2 is biased, the battery or power source 1870is coupled to the load or the main circuitry 1820 of the on bodyelectronics 110 (FIG. 1). With this connection from the battery 1870 todiode D2, diode D2 biases the N-channel MOSFET M2, and the resultingconnection maintains the connection from the battery 1870 to the load1820 as diode D2 will latch the gate of the N-channel MOSFET M2 evenafter the received RF signal has dissipated. In this manner, in certainembodiments, communication module 1640 (FIG. 16) of on body electronics110 (FIG. 1) includes an RF signal based turn on mechanism to initializeon body electronics 110 from the post manufacturing shelf mode. Incertain embodiments, display device 120 (FIG. 1) wirelessly transmitsthe RF turn on signal to on body electronics 110 in response to the useractivation or actuation of a command or a signal transmission.

In certain embodiments, the initial positioning and/or maintaining (fora given time period such as about 3-5 seconds, for example) of thedisplay device 120 within a predetermined distance from the on bodyelectronics 110 (after placement on the skin surface) may automaticallyinitiate the transmission of the RF turn on signal to the on bodyelectronics 110 for initialization. In certain embodiments, the RF turnon signal may include one of a plurality of predetermined OOK (On-OffKey) signals.

During post manufacturing shelf mode, on body electronics 110 drawslittle or no current from the power supply or battery. The internalprocessing component (such as for example, microprocessor or programmedlogic) and the oscillators are in inactive state. RF envelope detectorof on body electronics 110 may be configured to be triggered only upondetection of an RF signal from, for example, display device 120 that ispositioned within a predetermined distance or data communication rangeto on body electronics 110 (for initialization) such as within one inchor less, within 3 inches or less, within 5 inches or less, for example.

Alternatively, the on body electronics 110 may be provided or packagedwithin an RF shielding bag such as a foil pouch. When the RF signal isdetected by the envelope detector of on body electronics 110, the outputof the envelope detector is configured to control an electronic switchsuch as a field effect transistor (FET) that, when triggered, appliespower or draws power signals from the internal power source such as abattery and the processing component is temporarily latched on.

Referring now to FIG. 19 which illustrates data and/or commands exchangebetween on body electronics 110 and display device 120 during theinitialization and pairing routine, display device 120 provides andinitial signal 1921 to on body electronics 110. When the receivedinitial signal 1921 includes RF energy exceeding a predeterminedthreshold level 1903, an envelope detector of on body electronics 110 istriggered 1904, one or more oscillators of on body electronics 110 turnson, and control logic or microprocessors of on body electronics 110 istemporarily latched on to retrieve and execute one or more softwareroutines to extract the data stream from the envelope detector 1904. Ifthe data stream from the envelope detector returns a valid query 1905, areply signal 1922 is transmitted to display device 120. The reply signal1922 from on body electronics 110 includes an identification code suchas on body electronics 110 serial number. Thereafter, the on bodyelectronics 110 returns to shelf mode in an inactive state.

On the other hand, if the data stream from the envelope detector doesnot return a valid query from display device 120, on body electronics110 does not transmit a reply signal to display device 120 nor is an onbody electronics 110 serial number provided to display device 120.Thereafter, on body electronics 110 returns to shelf mode 1902, andremains in powered down state until it detects a subsequent initialsignal 1921 from display device 120.

When display device 120 receives the data packet includingidentification information or serial number from on body electronics110, it extracts that information from the data packet 1912. With theextracted on body electronics 110 serial number, display device 120determines whether on body electronics 110 associated with the receivedserial number is configured. If on body electronics 110 associated withthe received serial number has already been configured, for example, byanother display device, display device 120 returns to the beginning ofthe routine to transmit another initial signal 1911 in an attempt toinitialize another on body electronics that has not been configured yet.In this manner, in certain embodiments, display device 120 is configuredto pair with an on body electronics that has not already been pairedwith or configured by another display device.

Referring back to FIG. 19, if on body electronics 110 associated withthe extracted serial number has not been configured 1913, display device120 is configured to transmit a wake up signal to on body electronics110 which includes a configure command. In certain embodiments, wake upcommand from display device 120 includes a serial number of on bodyelectronics 110 so that only the on body electronics with the sameserial number included in the wake up command detects and exits theinactive shelf mode and enters the active mode. More specifically, whenthe wake up command including the serial number is received by on bodyelectronics 110, control logic or one or more processors of on bodyelectronics 110 executes routines 1903, 1904, and 1905 to temporarilyexit the shelf mode, when the RF energy received with the wakeup signal(including the configure command) exceeds the threshold level, anddetermines that it is not a valid query (as that determination waspreviously made and its serial number transmitted to display device120). Thereafter, on body electronics 110 determines whether thereceived serial number (which was received with the wake up command)matches its own stored serial number 1906. If the two serial numbers donot match, routine returns to the beginning where on body electronics110 is again placed in inactive shelf mode 1902. On the other hand, ifon body electronics 110 determines that the received serial numbermatches its stored serial number 1906, control logic or one or moremicroprocessors of on body electronics 110 permanently latches on, andoscillators are turned on to activate on body electronics 110. Further,referring back to FIG. 19, when on body electronics 110 determines thatthe received serial number matches its own serial number 1906, displaydevice 120 and on body electronics 110 are successfully paired 1916.

In this manner, using a wireless signal to turn on and initialize onbody electronics 110, the shelf life of on body electronics 110 may beprolonged since very little current is drawn or dissipated from on bodyelectronics 110 power supply during the time period that on bodyelectronics 110 is in inactive, shelf mode prior to operation. Incertain embodiments, during the inactive shelf mode, on body electronics110 has minimal operation, if any, that require extremely low current.The RF envelope detector of on body electronics 110 may operate in twomodes—a desensitized mode where it is responsive to received signals ofless than about 1 inch, and normal operating mode with normal signalsensitivity such that it is responsive to received signals at a distanceof about 3-12 inches.

During the initial pairing between display device 120 and on bodyelectronics 110, in certain embodiments, display device 120 sends itsidentification information such as, for example, 4 bytes of displaydevice ID which may include its serial number. On body electronics 110stores the received display device ID in one or more storage unit ormemory component and subsequently includes the stored display device IDdata in response packets or data provided to the display device 120. Inthis manner, display device 120 can discriminate detected data packetsfrom on body electronics 110 to determine that the received or detecteddata packets originated from the paired or correct on body electronics110. The pairing routine based on the display device ID in certainembodiments avoids potential collision between multiple devices,especially in the cases where on body electronics 110 does notselectively provide the analyte related data to a particular displaydevice, but rather, provide to any display device within range and/orbroadcast the data packet to any display device in communication range.

In certain embodiments, the payload size from display device 120 to onbody electronics 110 is 12 bytes, which includes 4 bytes of displaydevice ID, 4 bytes of on body device ID, one byte of command data, onebyte of spare data space, and two bytes for CRC (cyclic redundancycheck) for error detection.

After pairing is complete, when display device 120 queries on bodyelectronics 110 for real time monitored analyte information and/orlogged or stored analyte data, in certain embodiments, the responsivedata packet transmitted to display device 120 includes a total of 418bytes that includes 34 bytes of status information, time information andcalibration data, 96 bytes of the most recent 16 one-minute glucose datapoints, and 288 bytes of the most recent 15 minute interval glucose dataover the 12 hour period. Depending upon the size or capacity of thememory or storage unit of on body electronics 110, data stored andsubsequently provided to the display device 120 may have a differenttime resolution and/or span a longer or shorter time period. Forexample, with a larger data buffer, glucose related data provided to thedisplay device 120 may include glucose data over a 24 hour time periodat 15 minute sampling intervals, 10 minute sampling intervals, 5 minutesampling intervals, or one minute sampling interval. Further, thedetermined variation in the monitored analyte level illustratinghistorical trend of the monitored analyte level may be processed and/ordetermined by the on body electronics 110, or alternatively or inaddition to, the stored data may be provided to the display device 120which may then determine the trend information of the monitored analytelevel based on the received data packets.

The size of the data packets provided to display device 120 from on bodyelectronics 110 may also vary depending upon the communication protocoland/or the underlying data transmission frequency—whether using a 433MHz, a 13.56 MHz, or 2.45 GHz in addition to other parameters such as,for example, the availability of a data processing devices such as amicroprocessor (e.g., central processing unit CPU) in on bodyelectronics 110, in addition to the ASIC state machine, size of the databuffer and/or memory, and the like.

In certain embodiments, upon successful activation of on bodyelectronics 110 and pairing with display device 120, control unit ofdisplay device 120 may be programmed to generate and output one or morevisual, audible and/or haptic notifications to output to the user ondisplay 122, or on the user interface of display device 120. In certainembodiments, only one display device can pair with one on bodyelectronics at one time. Alternatively, in certain embodiments, onedisplay device may be configured to pair with multiple on bodyelectronics at the same time.

Once paired, display 122 of display device 120, for example, outputs,under the control of the microprocessor of display device 120, theremaining operational life of the analyte sensor 101 in user.Furthermore, as the end of sensor life approaches, display device may beconfigured to output notifications to alert the user of the approachingend of sensor life. The schedule for such notification may be programmedor programmable by the user and executed by the microprocessor ofdisplay device.

Embodiments of Display Devices

FIG. 20 is a block diagram of display device 120 as shown in FIG. 1 incertain embodiments. Referring to FIG. 20, display device 120 (FIG. 1)includes control unit 2010, such as one or more microprocessors,operatively coupled to a display 122 and a user interface 121. Thedisplay device 120 may also include one or more data communication portssuch as USB port (or connector) 123 or RS-232 port 2030 (or any otherwired communication ports) for data communication with a data processingmodule 160 (FIG. 1), remote terminal 170 (FIG. 1), or other devices suchas a personal computer, a server, a mobile computing device, a mobiletelephone, a pager, or other handheld data processing devices includingmobile telephones such as internet connectivity enabled smart phones,with data communication and processing capabilities including datastorage and output. Additional information on details of display deviceand other components of analyte monitoring system are provided in U.S.application Ser. Nos. 12/698,124, 12/699,653, 12/761,387, now U.S. Pat.No. 8,497,777, and U.S. Provisional Applications No. 61/325,155,61/325,021, the disclosure of each of which are incorporated byreference for all purposes.

Referring back to FIG. 20, display device 120 may include a strip port124 configured to receive in vitro test strips, the strip port 124coupled to the control unit 2010, and further, where the control unit2010 includes programming to process the sample on the in vitro teststrip which is received in the strip port 124. Any suitable in vitrotest strip may be employed, e.g., test strips that only require a verysmall amount (e.g., one microliter or less, e.g., about 0.5 microliteror less, e.g., about 0.1 microliter or less), of applied sample to thestrip in order to obtain accurate glucose information, e.g. FreeStyle®or Precision® blood glucose test strips and systems from Abbott DiabetesCare Inc. Display devices with integrated in vitro monitors and teststrip ports may be configured to conduct in vitro analyte monitoringwith no user calibration in vitro test strips (i.e., no humanintervention calibration), such as FreeStyle® Lite glucose test stripsfrom Abbott Diabetes Care Inc.

In certain embodiments, an integrated in vitro meter can accept andprocess a variety of different types of test strips (e.g., those thatrequire user calibration and those that do not), some of which may usedifferent technologies (those that operate using amperometric techniquesand those that operate using coulometric techniques), etc. Detaileddescription of such test strips and devices for conducting in vitroanalyte monitoring is provided in U.S. Pat. Nos. 6,377,894, 6,616,819,7,749,740, 7,418,285; U.S. Published Patent Publication Nos.2004/0118704, 2006/0091006, 2008/0066305, 2008/0267823, 2010/0094110,2010/0094111, and 2010/0094112, and U.S. application Ser. No.12/695,947, now U.S. Pat. No. 8,828,330, the disclosure of each of whichare incorporated herein by reference for all purposes.

Glucose information obtained by the in vitro glucose testing device maybe used for a variety of purposes, computations, etc. For example, theinformation may be used to calibrate analyte sensor 101 (FIG. 1) if thesensor requires in vivo calibration, confirm results of analyte sensor101 to increase the confidence in the results from sensor 101 indicatingthe monitored analyte level (e.g., in instances in which informationobtained by sensor 101 is employed in therapy related decisions), etc.In certain embodiments, analyte sensors do not require calibration byhuman intervention during its usage life. However, in certainembodiments, a system may be programmed to self-detect problems and takeaction, e.g., shut off and/or notify a user. For example, an analytemonitoring system may be configured to detect system malfunction, orpotential degradation of sensor stability or potential adverse conditionassociated with the operation of the analyte sensor, the system maynotify the user, using display device 120 (FIG. 1) for example, toperform analyte sensor calibration or compare the results received fromthe analyte sensor corresponding to the monitored analyte level, to areference value (such as a result from an in vitro blood glucosemeasurement).

In certain embodiments, when the potential adverse condition associatedwith the operation of the sensor, and/or potential sensor stabilitydegradation condition is detected, the system may be configured to shutdown (automatically without notification to the user, or after notifyingthe user) or disable the output or display of the monitored analytelevel information received from the on body electronics assembly. Incertain embodiments, the analyte monitoring system may be shut down ordisabled temporarily to provide an opportunity to the user to correctany detected adverse condition or sensor instability. In certain otherembodiments, the analyte monitoring system may be permanently disabledwhen the adverse sensor operation condition or sensor instability isdetected.

Referring still to FIG. 20, power supply 2020, such as one or morebatteries, rechargeable or single use disposable, is also provided andoperatively coupled to control unit 2010, and configured to provide thenecessary power to display device 120 (FIG. 1) for operation. Inaddition, display device 120 may include an antenna 2051 such as a 433MHz (or other equivalent) loop antenna, 13.56 MHz antenna, or a 2.45 GHzantenna, coupled to a receiver processor 2050 (which may include a 433MHz, 13.56 MHz, or 2.45 GHz transceiver chip, for example) for wirelesscommunication with the on body electronics 110 (FIG. 1). Additionally,an inductive loop antenna 2041 is provided and coupled to a squarewavedriver 2040 which is operatively coupled to control unit 2010.

In certain embodiments, antenna configurations including loop antennaconfigurations are provided for display device 120 for datacommunication at Ultra High Frequency (UHF) frequency bands, providing areal time analyte data acquisition system that includes display device120 which is configured to generate a strong near electromagnetic fieldto provide power to on body electronics 110 to receive sampled and/orprocessed analyte related data from on body electronics 110. Suchconfiguration also provides a weak far electromagnetic field such thatthe strength of the generated magnetic field at a far distance, such asabout 3 meters away or 4 meters away or more from on body electronics110 maintains the data communication range between on body electronics110 and display device 120. In certain embodiments, display device 120may be configured for RF transmission at any frequency.

FIG. 21A is a schematic of the display device for use in the analytemonitoring systems of FIG. 1 in certain embodiments. Referring to thefigure, display device 120 (FIG. 1) configured to provide RF power tothe on body electronics 110 (FIG. 1) in accordance with one aspect ofthe present disclosure, includes a surface acoustic wave (SAW) resonator2101 which may include a resonator that generates the RF signaloperating in conjunction with an oscillator (OSC) 2102. The oscillator2102 is the active RF transistor component, and in conjunction with theSAW resonator 2101, is configured to send out control commands (the pingsignals), transmit the RF power to receive the backscatter signal fromthe on body electronics 110, and generate local oscillation signal tothe mixer 2103, as described in further detail below.

More specifically, in certain embodiments, in operation, the transmitdata (TX data) as shown is the control signal generated by the controlunit of the display device 120 (FIG. 1), and an RF control command fromthe power amplifier (PA) 2106, is configured for transmission to on bodyelectronics 110. SAW resonator 2101 in certain embodiments is configuredto provide the carrier signal for the control commands (ping signals).The control signal from display device 120 (FIG. 1) in certainembodiments includes data packets that are to be transmitted to on bodyelectronics 110 to ping or prompt on body electronics 110, and torequest for a response packet back display device 120.

In one embodiment, before the control signal is sent, a turn on signalfrom control unit of display device 120 is received at the TX enableline (as shown in FIG. 21A) and provided to oscillator 2102. After thecontrol signal from the control unit is provided to oscillator 2102 andSAW resonator 2101, the carrier signal which is used to carry thecontrol signal is maintained. The same carrier signal in one embodimentmay be used to receive the response data packet from on body electronics110 (FIG. 1).

When the RF control signal is provided to on body electronics 110 usingthe loop antenna and over the carrier signal, the RF power is providedat the same time (radiation energy) where the RF power is generated byoscillator 2102 in conjunction with SAW resonator 2101. In certainembodiments, because the carrier signal is maintained duringtransmit/receive time periods between display device 120 and on bodyelectronics 110, the RF power is provided during the ping (or controlsignal) request transmission of the RF control signal, and also duringthe time period when the backscatter response is received from on bodyelectronics 110. In certain embodiments, loop antenna 2108 of displaydevice 120 uses the same carrier signal to transmit the RF power and theRF control signal to on body electronics 110, while in other embodimentsdifferent carrier signals are used.

Referring back to FIG. 21A, further shown is LC power splitter 2104which is configured in certain embodiments to split the power twoways—to buffer 2105 and to power amplifier (PA) 2106. Buffer 2105 incertain embodiments is configured to boost the RF signal received fromLC power splitter 2104. Output of power amplifier 2106 is a controlcommand that is provided to a second LC power splitter 2107 which splitsthe antenna signal (from the loop antenna into transmit signal (thecontrol signal) and the receive signal (backscatter signal from on bodyelectronics 110)). That is, in one embodiment, second LC power splitter2107 may be configured to manage the transmit/receive signals using oneloop antenna 2108. Referring again to FIG. 21A, in certain embodiments,a balun 2109 provided between the loop antenna 2108 and the second LCpower splitter 2107 is used in one embodiment to match the balancedsignal from the loop antenna 2108 to the unbalanced signal from thepower splitter 2107 (as most circuit components are unbalanced relativeto ground terminal). Balun 2109 includes, in certain embodiments, anelectrical transformer that converts electrical signals that arebalanced about ground (differential) to signals that are unbalanced(single-ended), and vice versa, using electromagnetic coupling foroperation.

Referring still to FIG. 21A, loop antenna 2108 transmits the RF controlsignal (the ping signal) and in response, receives a response packetfrom on body electronics 110. In one aspect, the received responsepacket by the loop antenna is passed through the balun 2109, and viapower splitter 2107 to SAW filter 2111. SAW filter 2111 in certainembodiments includes a bandpass filter configured to remove noise orinterference components in the received response packet, for example.The output of SAW filter 2111 is passed through ASK receiver 2120. Inone aspect, ASK receiver 2120 includes low noise amplifier (LNA) 2121whose output is sent to mixer 2103 which mixes the low noise amplifiedsignal output from LNA 2121 with the RF carrier signal from buffer 2105.

The output of mixer 2103 is passed to high pass filter (HPF) 2112 thatfilters out the DC component and low frequency components of the signal,and then the output of HPF 2112 is sent to the intermediate frequencyamplifier (IF amplifier) 2113 which is configured to amplify thereceived signal. The amplified output signal from IF amplifier 2113 isprovided to the low pass filter (LPF) 2122 of ASK receiver 2120, and theoutput low pass filtered signal from LPF 2122 is provided to anotherintermediate frequency amplifier 2123 of ASK receiver 2120 which isconfigured to amplify the low pass filtered signal output from the LPF2122. As shown in FIG. 21A, IF amplifier 2123 of ASK receiver 2120 isprovided between LPF 2122 and ASK demodulator 2124.

Referring yet still to FIG. 21A, the gain controller signal from IFamplifier 2123 of ASK receiver 2120 controls the LNA 2121 that receivesthe filtered backscatter signal. The gain controller signal in oneembodiment switches between high gain and low gain state of LNA 2121.For example, if IF amplifier 2123 has high gain, then the gaincontroller signal to LNA 2121 switches the LNA 2121 to low gainoperation, and vice versa. As discussed above, the output of the IFamplifier 2123 of ASK receiver 2120 is provided to ASK demodulator 2124of ASK receiver 2120 which is configured to demodulate (or recover thedata) the output signal from IF amplifier 2123.

That is, as shown in FIG. 21A, the RX enable line to ASK receiver 2120is configured to turn on after the TX enable line where the turn onsignal from the control unit is received in display device 120 such thatwith the receive enable signal from the control unit, the data out line(i.e., the output of ASK demodulator 2124) of ASK receiver 2120 providesthe data or signal associated with the monitored glucose level based onthe raw current signals from analyte sensor 101 (FIG. 1).

Referring again to FIG. 21A, in certain embodiments, an RF transmitterchip or an ASK transmitter may be included in display device 120(FIG. 1) to replace the SAW resonator 2101, oscillator 2102, mixer 2103,LC power splitter 2104, buffer 2105, power amplifier 2106, high passfilter (HPF) 2112, and IF amplifier 2113 shown in FIG. 21A. Morespecifically, in this embodiment, the RF transmitter chip may be coupledto a crystal which provides the frequency reference base for generatingthe RF carrier signal to receive the backscatter signal from on bodyelectronics 110, and also to send the control commands (ping signals) toon body electronics 110.

In the embodiment discussed above, the RF transmitter chip or unit maybe coupled to the LC power splitter, a balun and the loop antennasimilar to the LC power splitter 2107, balun 2109, and loop antenna 2108shown in FIG. 21A, in addition to a SAW filter and ASK receiver similarto the SAW filter 2111 and ASK receiver 2120 shown in FIG. 21A. However,compared to the configuration shown in FIG. 21A, in alternateembodiments, another crystal may be coupled to the ASK receiver toprovide the frequency reference base for receiving the backscattersignal from on body electronics 110.

FIG. 21B illustrates a block diagram of display device 120 in theanalyte monitoring system 100 of FIG. 1 in certain embodiments.Referring to FIG. 21B, and in conjunction with FIG. 1, display device120 includes control unit 2150 operatively coupled to the components asshown in the Figure including input/user interface 2151, display 2152,memory 2153, and RFID transceiver 2156. As further shown in FIG. 21B,RFID transceiver 2156 in certain embodiments is operatively coupled tomatching circuit/filter 2155 that is coupled to antenna 2154. Matchingcircuit/filter 2155 in certain embodiments is configured to tune and/ormatch the signals between the on body electronics 110 (FIG. 1) anddisplay device 120, sent and received via antenna 2154. Antenna 2154, incertain embodiments includes a 13.56 MHz RFID antenna where RFIDtransceiver 2156 is configured to operate in the 13.56 MHz frequency. Incertain embodiments, RFID transceiver 2156 may include a userprogrammable modulation depth in write mode where data or command issent, whereas single subcarrier, frequency shift keying (FSK) and phaseshift keying (PSK) modulations are recognized in the read mode wheredata is received from on body electronics 110, for example. Moreover, alogarithmic amplifier may be used for single subcarrier detection fordata recovery from on body electronics 110.

Referring again to FIG. 21B, control unit 2150 in certain embodimentsinclude one or more microcontrollers or processors, ASIC with programmedlogic for execution by one or more state machines for controlling andexecuting the operation of the reader (FIG. 1). Memory 2153 in certainembodiments includes volatile memory and/or non-volatile memory for datastorage.

In certain embodiments, data communication between on body electronics110 and display device 120 may be achieved at the 2.45 GHz ISM band. Incertain embodiments, display device 120 (FIG. 1) is configured to listenfor a clear channel on 2.45 GHz radio frequency band. When a clearchannel is detected and selected, a clear channel identifier is sent toa control unit of an on body electronics 110 (FIG. 1). After the clearchannel identifier is received, the data packets are provided to thereceiver unit. Thus, the power drain of the “listen before talk” processrequired of operation in the 2.45 GHz ISM band, comes off of the largerbatteries in display device 120, conserving power in the on bodyelectronics 110.

An exemplary process for using this communications system is illustratedin the schematic diagram of FIG. 22 in conjunction with the routineshown in FIG. 23. When the user desires or requires an analyte reading,such as a current glucose level, and/or wants to collect logged analytedata, display device 120 can be used to find a clear channel (2201) onthe 2.45 GHz band (2221), and then, to separately send an OOK (or othersuitably modulated) message to the on body electronics 2211,communicating a clear frequency identifier (2202). On body electronics2211 then responds with a high-baud rate stream of data packets,transmitted over the clear channel (2203). With this procedure, on bodyelectronics 2211 does not have to perform the “listen to talk” routinebecause this routine has been conducted by the display device 120.

Referring again to FIGS. 22-23, in certain embodiments, display device120 may include an RF transceiver, with an RF transmitter on the 2.45GHz band coupled to antenna 2214 (schematically shown as external;however, the antenna may be mounted internally to the display device120). It also may have a digitally modulated RF signaling function,which can be an OOK signaling function, either in the 2.45 GHz band orsome other band (in which case there could be a second antenna on thereceiving unit (not shown)). The on body electronics 2211 in certainembodiments includes a data processing unit in which the power supplymay be a small battery, and the RF transmitter/receiver can be a lowpower 2.45 GHz transceiver, e.g., a Texas Instruments® CC2510 integratedcircuit, which, in addition to the 2.45 GHz radio, also provides amicroprocessor (CPU), memory, analog-to-digital conversion (ADC), andsignal processing functions.

In certain embodiments, the RF communication component of the on bodydevice 2211 may be coupled to antenna 2213 (schematically shown asexternal; however, the antenna may be mounted internally to the on bodydevice 2211). The on body electronics 2211 may also have a receivercapable of receiving a digitally modulated signal containing a clearchannel identifier. In this regard, the RF transceiver may be configuredas an ultra low power OOK receiver that requires extremely low power tolisten, but only has a limited listening range. The listening range issufficient, however, to be operable when the receiver unit 120 is inproximity to the on body electronics 2211, for example when one unit isplaced next to the other within a predetermined distance of for example,less than about 10 inches, less than about 5 inches, less than about 3inches, or less than about one inch, or any other suitable distance.

In certain embodiments, data packets received from on body electronicsand received in response to a request from display device, for example,include one or more of a current glucose level from the analyte sensor,a current estimated rate of glycemic change, and a glucose trend historybased on automatic readings acquired and stored in memory of on skinelectronics. For example, current glucose level may be output on display122 of display device 120 as a numerical value, the current estimatedrage of glycemic change may be output on display 122 as a directionalarrow 131 (FIG. 1), and glucose trend history based on stored monitoredvalues may be output on display 122 as a graphical trace 138 (FIG. 1).In certain embodiments, microprocessor of display device 120 may beprogrammed to output more or less information on display 122, andfurther, the type and amount of information output on display 122 may beprogrammed or programmable by the user.

In certain embodiments, display device 120 is programmed to maintain atime period between each consecutive of analyte data request from onbody electronics 110. For example, in certain embodiments, displaydevice 120 is configured such that after an initial analyte data requesthas been sent to on body electronics 110, and the monitored analytelevel information received from on body electronics 110, display device120 disallows a subsequent analyte data request to be sent to on bodyelectronics 110 until a predetermined time period has elapsed measuredfrom the transmission of the initial analyte data request. For example,when display device 120 is operated to send to on body electronics 110 arequest for analyte related data, an internal clock or timer of thedisplay device 120 starts or activates the internal clock or timerprogrammed with a predetermined time period to count down. Displaydevice 120 in certain embodiments include programming to disable orprevent sending the second, subsequent request for analyte data from onbody electronics 110 until after the predetermined time period haselapsed.

In certain embodiments, the predetermined time period includes about 120seconds, about 90 seconds, about 60 seconds, or about 30 seconds orless. The predetermined time period in certain embodiments is determinedby the time period for performing analog to digital conversion by onbody electronics 110 to convert the sampled signal from monitoring theanalyte level to a corresponding digital signal for transmission and/orthe sampling period of analyte sensor 101, monitoring analyte levelevery minute, or every 5 minutes, or every 10 minutes or other suitabletime interval. The time interval in certain embodiments may bepre-programmed as software logic in on body electronics 110, oralternatively, is programmable and can be modified during in vivo sensoruse.

In certain embodiments, display device 120 requires a minimum timeperiod to elapse between each successive analyte data request from onbody electronics 110 to avoid corrupting the data in on body electronics110. For example, when the analog to digital (A/D) conversion routine isbeing executed by on body electronics 110 (for example, during theinitial 30 second window for each 1 minute sampling period associatedwith analyte sensor 101), display device 120 transmits an analyte datarequest (for example, the RF power level from display device 120 maydisrupt the A/D conversion routine) or otherwise corrupt the dataresulting from the A/D conversion routine being executed by on bodyelectronics 110. Accordingly, in certain embodiments, display device 120is programmed to disallow sending a request for analyte data from onbody electronics (110) (for example, performing a read function bydisplay device 120) during an (A/D) conversion cycle in on bodyelectronics 110. Accordingly, the time interval between data requestsfrom display device 120 ensures that the A/D conversion routine iscomplete in on body electronics 110 when display device 120 sends thedata request to on body electronics 110.

In certain embodiments, display device 120 may be programmed orprogrammable to discard or identify received data from on bodyelectronics 110 that is corrupt or otherwise includes error. Forexample, in certain embodiments, a minimum time period betweensubsequent analyte data request is not enforced or programmed in displaydevice 120. However, display device 120 includes software routines thatcan identify data that is corrupt or not based on examining the datapacket. For example, each data packet received from on body electronics110 includes a single bit or a byte or other suitable portion of thedata packet that provides an indication of the data status. In the caseof a single bit as the data status identifier in the data packet from onbody electronics 110, in certain embodiments, a value of 1 indicatesthat the data is not corrupt. In such embodiments, on body electronics110 is configured to reset this bit in the data packet to 0 at the endof each sampling period (for example, after each minute), and change thevalue to 1 when the A/D conversion routine is completed during thesampling period without error.

Embodiments of Data Processing Routines

In certain embodiments, data from on body electronics 110 (FIG. 1)provided to display device 120 may include raw monitored analyte leveldata, measured or monitored temperature data, stored past monitoredanalyte level data, analyte level trend data (such as a series ofconsecutive or near consecutive data points corresponding to themonitored analyte level) that was stored or buffered in the on bodyelectronics for a predetermined time period, since the activation of theon body electronics, or since the time period when the last data packetor signals were provided to the display device, or any one or morecombinations of the above. For example, the historical informationconstructed by a series of consecutive and/or near consecutive datapoints corresponding to the monitored analyte level may indicate thevariation in the monitored analyte level over the particular time periodbased on signals received from the analyte sensor and stored in the onbody electronics.

In certain embodiments, display device 120 is configured to determineand adjust for deviation or drift of time base in on body electronics110 such that the analyte sensor 101 life is monitored and accuratelyterminated upon expiration of its useful time period. In certainembodiments, on body electronics 110 include limited storage capacity inits memory (for example, storing the past 24 hours, or 12 hours, or 8hours, or 5 hours of logged data, overwriting the older data). In suchcases, if the sensor is not disabled when it reaches the end of itsuseful life time period (for example, 10 days, or seven days, or fivedays, or three days), the logged data will be overwritten by new datagenerated from the expired sensor.

More specifically, FIG. 24 is a flowchart illustrating a routine fordetermining the sensor expiration information by display device 120 forcommunication to on body electronics in certain embodiments. Displaydevice 120 is configured to track time information accurately based onits internal clock(s). In certain embodiments, on body electronics 110is programmed with total sample number information that corresponds tothe sensor life duration. For example, if the sensor is a 10 day sensor,and it is configured to sample analyte level in ISF once every minute,the total sample number for the 10 day analyte sensor is 14,400 samples(60 mins/hr*24 hrs/day*10 days). When display device 120 receives a datapacket with the sample number information from on body electronics 110,display device 120 in certain embodiments includes software routinesthat are executed to determine, based on the sample number received fromthe on body electronics 110 and time information from the internal clockor crystal of the display device 120, the correct total sample numberfor the sensor 101.

For example, referring to FIG. 24, when display device 120 receives adata packet from on body electronics 110 (2410), microprocessor orcontroller of display device 120 extracts sample number informationassociated with the received data packet in addition to other data suchas current analyte level data, current temperature data, storedhistorical monitored analyte data, for example (2420). Display device120 then retrieves the analyte sensor expiration information (forexample, in time based unit such as 14,400 minutes for 10 day sensors)and multiplies the retrieved sensor expiration time information with thereceived sample number (2430). The resulting value from themultiplication is then divided by the time elapsed since sensorinitialization (measured, for example, in time based units) (2440),resulting in the corrected expiration sample number for the analytesensor.

When the display device 120 is in subsequent communication with on bodyelectronics 110, the determined expiration sample number is transmittedto on body electronics 110. On body electronics 110, in turn, stores thereceived expiration sample number, and compares the sample number foreach sampled analyte from the analyte sensor, and when the sample numbercorresponding to the sample analyte level from the analyte sensormatches or exceeds the received expiration sample number, on bodyelectronics 110 is programmed to no longer log data. In this manner, incertain embodiments, display device 120 is configured to determinecorrection to the sensor expiration or end of life time period for thesensor, and communicate the adjustment or correction to on bodyelectronics 110 so that data logged from unexpired analyte sensor is notoverwritten by data from sensor whose useful life has ended.

In the manner described above, a first order model is provided tocorrect for sensor expiration time period deviation. In certainembodiments, second or higher order models or polynomials may be used toimprove accuracy of the sensor life expiration determination. Forexample, the first order model described in conjunction with FIG. 24assumes that the on body electronics time reference remainssubstantially constant during the sensor life. In cases where the timereference does not remain constant during the sensor life, a weighingfunction may be introduced such that, different weighing function isapplied at the initial stage of sensor life compared to the later stageof the sensor life, such that the average value over the course of thesensor life more accurately represents the true sensor expiration timeperiod.

Furthermore, in certain embodiment, the time base of the on bodyelectronics may accumulate error continuously from the start of thesensor life until the last sampled data logged at the end of the sensorlife. In certain embodiments, display device 120 may be configured todetermine a precise time-sample number pair each time data packet isreceived from on body electronics 110. To address the accumulation oferror in on body electronics time base, display device 120 in certainembodiments, for each data packet received from on body electronics 110,display device 120 determines a new time-sample number pair. By keepingthe previous time-sample pair, the display device 120 may perform piecewise interpolation to determine the actual time of each sample loggedand received from on body electronics 110.

For example, at sample time t=980 (e.g., elapsed time since sensorinsertion and initialization), with sample number of 1,000, and atsample time t=2020 corresponding to sample number 2000, piece wiseinterpolation yields an increment in time t of 104 for each increment of100 in sample number as shown below:

TABLE 1 Sample Number Time 1000 980 1100 1084 1200 1188 1300 1292 14001396 1500 1500 1600 1604 1700 1708 1800 1812 1900 1916 2000 2020

As can be seen in conjunction with Table 1 above, in certainembodiments, using interpolation based on the two sample number—timepairs, actual sample time for each sample can be determined, and anyerror accumulated or introduced by on body electronics 110 may becorrected.

Referring back to the Figures, an exemplary implementation of the onbody electronics adapted to process signals from the analyte sensor andto provide the processed or raw signals to the display device inresponse to such data request or upon demand is shown in FIG. 25.Referring to FIG. 25, there are provided a sensor 2511, clock 2519,processor 2517 and input/output (I/O) interface 2513. The functions ofthe memory are performed in part by shift register 2523. Shift register2523 provides storage locations for n measurements from most currentmeasurement T1 to the nth past measurement T1−(n−1). Each storagelocation T1−x provides an output into a multiplier, each configured toinput a multiplicative weighting factor mx. Each multiplier product isinput into a corresponding summer Sx, and the summers are chained toprovide a composite weighted sum (weighted average) in summer S0.Processor 2517 may also be adapted to read the individual values T1 toT1−(n−1), and possibly individual sums. The multiplicative weighingfactors may also be adjustable through processor 2517, responsive totwo-way communications from a commanding device such as the displaydevice 120 (FIG. 1). In certain embodiments a weighing factor in binaryform may be used, which could be adjusted by a series of left or rightshifts. This implementation might further include a similar (but likelysmaller) additional shift register-multiplier-summer structure (notshown) to store a sequence of averages from summer S0, and provide amoving average of those averages, whose values and averages would belikewise provided to processor 2517.

Certain embodiments may be used to efficiently determine, store andprovide upon request, the real time monitored analyte data, averagedanalyte data and/or rate-of-change information of the monitored analyte.For example, a moving average may be used to indicate a trend in themonitored analyte level. If, for example, there were four storageelements (n=4), receiving shifted-in analyte measurement data once perminute, a multiplier of 1/n (e.g., ¼) may be used, in which case thetrend or variation in the monitored analyte level may be regarded as theaverage of the past four samples. In another example, trend data mightbe the average of the third and fourth samples, in which case theweighing factors would be 0, 0, ½ and ½. In one embodiment, there may be15 storage elements (with sensor data again collected once per minute),with two calculated trends—the first over the past 10 minutes and thesecond over the full 15 minutes. In addition on body electronics maystore selected data on a long term basis, for example once every 15 or20 minutes, for an extended wear period of on body unit 1 (e.g., up toseveral weeks).

Other approaches involving the determination of the analyte level and/ortrend information or like or analogous components used for the same willbe apparent to those of skill in the art. For example, the firstlocation and the second location may be the same, e.g., data isoverwritten. FIG. 26 shows a further memory structure that may beemployed, which stores long term data at a slower sampling rate (shortterm trend vs. long term history). In one embodiment, clock signal 2551,e.g., a one-minute clock, may be divided by N in clock divider 2552. Nmay be any desired number, for example, 5, 10, 15, 20, 60 or otherdesired value in order to generate the desired time base formeasurements. In certain embodiments, an analyte measurement may bedetermined (and not immediately provided to the display device), andstored in a memory or storage location. In one embodiment, an n-positionshift register may be employed for this purpose, in which eachmeasurement 2553-1, etc. to 2553-n is sequentially entered and shiftedin the shift register. The most recent measurement at any time will be2553-1. Alternatively, the memory or storage employed for this purposemay be addressable, and used as a circular buffer, with a pointer to themost recent measurement value. In certain embodiments (not shown), twoor more sections as illustrated in FIG. 26 may be cascaded, to provide aplurality of further spaced apart measurements, e.g., over a period ofhours.

FIGS. 27A-27D illustrate routines to determine periodic and/or averagedand/or rate-of-change data from monitored analyte level in analytemonitoring system 100 of FIG. 1. Referring to the Figures, a time or aseries of times for taking sensor measurements may be derived from clockpulses, and separate measurements taken at such time or times (2710). Incertain embodiments, a series of measurements (2715) may be digitizedand directly recorded (2720, 2725). In other embodiments, a calculation,such as a rolling average of measurements, may be performed (2720) andthe resulting value recorded (2725). In either case, at least oneelement (e.g., a measurement or an average) may be recorded or stored ina memory location of a memory device in on body electronics 110. Asecond computation may then be performed based upon the stored value(s),and the results of the computation again stored (e.g., each new analytemeasurement may be accompanied by the further calculation (2720) of anupdated average value or rate data). This process may be repeatedcontinuously (e.g., returning to 2710), such that at any time there maybe stored in on body electronics 110, or other storage device, whateverdata is of interest, e.g., a sequence of measurements, a sequence ofaverages, and/or a current moving average of some number (n) of priormeasurements.

Responsive to a user command (by actuation of a switch on the displaydevice 120 (FIG. 1) or by positioning the display device 120 (FIG. 1)within a predetermined distance to on body electronics 110 (2730), themonitored analyte level information from the analyte sensor is providedto display device 120. In some embodiments, the user command is a userinput, such as pressing a button or an actuator. In other embodiments,the user command includes both placing the display device 120 and onbody electronics 110 within a defined communication range as wellproviding a user input.

Referring now to FIGS. 27A and 27B, in certain embodiments, afterstarting or initiating the data processing routine (2705), a processoror programmed logic of the on body electronics 110 (FIG. 1) may beconfigured to verify one or more signals from a clock and determine,(2710), whether it was time to take a sensor measurement. If yes, thenanalyte sensor 101 reading is acquired by on body electronics 110(2715). This value could be used as is (a measurement point), orprocessed in some manner (e.g., to calculate an updated rolling averagebased on a past rolling average), and the result (from 2720) stored in amemory location in the on body electronics 110 (2725). The measurementor rolling average points will be referred to as data set 1, and thestored data will be referred to as data set 2. The process may repeat ina loop (2710). In embodiments in which a plurality of storage locationsis provided, new values are continuously stored, and the oldest valuesdeleted or de-referenced.

At any time unrelated to the state of cycling of loop 2710-2725, a usermay initiate a data request (2730). This will start a sub-process inwhich one or more values of interest may be loaded from the storage ofdata set 2 (2735). The selection, which may or may not be a differentset, will be referred to as data set 3. Data set 3 may be subjected tooptional further processing within on body electronics 110 (2740). Forexample, where data set 2 is a sequence of periodic analyte measurementsthe routine includes calculating a weighted moving average of themeasurements and/or filtering, or the like (2740). The data set 3 datais reported to display device 120 (2745). For example, the data set 3data could include a series of periodic sensor measurements plus movingaverage data.

As shown in FIG. 27C, the routine may also include a rate-of-change ofthe monitored analyte level determination (2780). For example, a currentanalyte sensor measurement may be retrieved (2731) and based on which arate-of-change information of the monitored analyte level may bedetermined. For example, referring to FIG. 27D, data set 2 may be thesame as data set 1 (2790), and includes a set of periodic analytemeasurements, which are stored (2791). Referring again to the Figure,the most current analyte measurement and a moving average are determined(2792), computing a rate of change on that basis (2793). Within thescope of the present disclosure, different rates may be provided bycomparison to averages determined in different ways or over a differentnumber of measurements.

Where a plurality of storage elements are used, for instance, nelements, storing a data element could be accompanied by freeing thespace occupied by the nth previously recorded element, for example byoverwriting data, physically shifting data in a register, pushing orpopping data from a stack structure, queuing or dequeuing data from aqueue, or by changing pointers into a memory area in some other manner.

In embodiments in which averages are calculated, the averages may beweighted averages. In a simple case, the weighting factors could all beequal. Alternatively, certain factors could be reduced to zero in orderto eliminate one or more measurements. Alternatively, weighting factorscould be varied to attenuate or emphasize data from specific points intime. In some embodiments, where the data of interest is a sequence ofmeasurements, the second calculation referred to above could be bypassedby simply using the first values recorded (e.g., without calculating orstoring an average).

Where an average has been calculated and recorded or stored, a furthercalculation may be performed and the results used for further processingand/or communicating the results to another device or remote location,reflecting a further calculation performed on a current measurement andthe average. For example, comparison of a current reading with a storedmoving average would be a value indicative of the current analyte levelrate of change or analyte data trend information. Additionally,successive rate-of-change figures may be recorded or stored in order toprovide for the calculation of a moving average rate-of-change thatmight be less noisy than an instantaneous figure based on a singlemeasurement compared to an average.

FIG. 28 is a flowchart illustrating a glucose data acquisitionnotification routine in certain embodiments. Referring to FIG. 28, inone aspect, the display device 120 (FIG. 1) or a similar controller ordata processing device may be configured to generate an outputnotification such as audible, vibratory, visual, or one or morecombination notifications to indicate a successful glucose dataacquisition received from the on body electronics 110 (FIG. 1) in signalcommunication with an analyte sensor such as a glucose sensor. That is,referring to FIG. 28, upon receipt of the analyte related responsesignal or data packet (2810), the display device 120 generates andasserts a first notification (2820) which may be a short audible tone.In certain embodiments, the first notification may be programmed indisplay device 120, or may be programmable by the user with customizedoutput alert such as a ring tone, or a visual output (for example, aflashing indication on the screen of the display device) representingsuccessful real time glucose data acquisition or receipt from the onbody electronics 110. In certain embodiments, receipt of the analyterelated response signal or data packet (2810) is received in response toa request for the real time analyte data using, for example, RFIDtechniques, to acquire data in response to a data request (e.g., ondemand).

In certain embodiments, the first notification may be programmed to beautomatically asserted when the desired glucose data is received whenthe display device 120 is positioned within the predetermined distancefrom the on body electronics 110 to receive the backscatter signal fromthe on body electronics 110.

Referring again to FIG. 28, after the assertion of the firstnotification, it is determined whether stored analyte data issubsequently or concurrently received with the real time glucose data(2830). That is, in one aspect, in addition to the glucose data receivedfrom the on body electronics 110, display device 120 may be configuredto receive additional glucose related information such as stored priorglucose data, sensor related data, such as sensor manufacturing code,calibration information, sensor status, device operational statusinformation, updated battery life status of the device or any otherinformation that may be provided to the display device 120 from the onbody electronics 110. In aspects of the present disclosure, theadditional or other information detected by the display device 120including, for example, stored prior analyte data may be received afterthe real time glucose data acquisition. Alternatively, this additionaldata may be received concurrent or substantially contemporaneous to thereceipt of the real time glucose data.

When the receipt of stored analyte data and/or other additionalinformation is detected (2830), display device 120 in one aspect of thepresent disclosure may be configured to assert a second notification(2840) such as an audible alarm, alert, output tone, a ring tone, avibratory indication, a visual output indication, or one or morecombinations of the above to notify the user that the additionalinformation has been successfully acquired or received by the displaydevice 120. On the other hand, if it is determined that the additionalinformation is not received by the display device 120, then the routineterminates.

In certain aspects, the assertion of the first notification and/or thesecond notification depends upon the duration of positioning the displaydevice 120 in close proximity and within the short RF range of the onbody electronics 110. That is, when the display device 120 is positionedwithin the communication range of the on body electronics 110 totransmit the request for glucose data, and in response, receives aresponsive data packet including the real time glucose information, thedisplay device 120 alerts the user with the first notification toconfirm and/or notify the user that the real time glucose data has beensuccessfully acquired or received from the on body electronics 110.Thereafter, if the display device 120 is maintained within substantiallythe same distance or closer to the on body electronics 110 for anextended or further time period, and the display device 120 detects thereceipt of additional information or data packets from the on bodyelectronics 110 (including, for example, historical or stored priorglucose related information), the display device 120 in one embodimentasserts the second notification or alert to the user to confirm and/ornotify that additional information has been successfully received fromthe on body electronics 110.

In this manner, by positioning the display device 120 within apredetermined distance to the on body electronics 110, the user canreceive or acquire real time and/or optionally historical glucose dataand provided with confirmation notification of successful dataacquisition, for example, with a first notification indicatingsuccessful real time glucose data acquisition, and a second notificationindicating successful data acquisition of additional glucose or devicerelated data. In certain embodiments, the first and second notificationsmay be the same, or different in characteristics. For example, in theembodiment where the notifications are audible tones, each of the firstand second notifications may have different tone duration, pitch, andthe like. Alternatively, the first and second notifications may shareone or more characteristics (such as the pitch), but with at least oneunique characteristic (such as duration of the tone), such that the twonotifications can be distinguished. Furthermore in accordance withaspects of the present disclosure, additional notifications may beprogrammed or provided to the display device 220 (or customized by theuser) to include, for example, multiple output notifications eachassociated with a particular data acquisition mode or event.

In certain embodiments, analyte monitoring systems may be calibrated aspart of manufacturing and shipped as already calibrated. FIG. 29 is aflowchart illustrating sensor calibration achieved as part ofmanufacturing in certain embodiments. Referring to FIG. 29, adetermination of sensor sensitivity is performed during manufacture(2910). A calibration number is then assigned in connection with thesensor sensitivity determined during manufacture (2920). Then the useris instructed to enter, and in response thereto enters, the calibrationnumber into the receiver unit (such as the display device 120 of FIG. 1)(2930). Using the sensor sensitivity information associated with thecalibration number, after receiving analyte sensor measurement (2940),the display device processes the analyte sensor measurement data inconjunction with the sensor sensitivity information to calibrate theanalyte monitoring system.

In certain embodiments, the analyte monitoring system may be calibratedas part of manufacturing and may require no user calibration. In otherembodiments, the analyte monitoring system may not require anycalibration, including factory calibration. Further detailed descriptionregarding analyte sensors and sensor systems that do not requirecalibration by human intervention is provided in U.S. patent applicationSer. No. 12/714,439, the disclosure of which is incorporated herein byreference in its entirety for all purposes. Moreover, further detailsrelated to calibration and obtaining system measurements of continuousanalyte monitoring systems can be found in, for example, U.S.publication nos. 2009/0005665; 2008/0288204; 2008/0006034; 2008/0255808;2008/0256048; 2009/0006034; 2008/0312842; 2008/0312845; 2008/0312844;2008/0255434; 2008/0287763; 2008/0281179; 2008/0288180; 2009/0033482;2008/0255437; and 2009/0036760; and U.S. provisional application No.61/247,508, the disclosures of each of which are incorporated in theirentirety by reference for all purposes.

In certain embodiments, calibration of the analyte sensor by humanintervention is not required, and therefore not performed prior to theoutput of clinically accurate analyte data. For example, the tolerancesachieved during manufacturing and/or stability of a given sensor overtime may be such that calibration by human intervention is not required,see for example, U.S. patent application Ser. No. 11/322,165, now U.S.Pat. No. 8,515,518, Ser. Nos. 11/759,923, 61/155,889, 61/155,891, and61/155,893, the disclosures of each of which are incorporated byreference in their entireties herein for all purposes.

Referring back to FIG. 1, in certain embodiments, analyte monitoringsystem 100 may store the historical analyte data along with a dateand/or time stamp and/or and contemporaneous temperature measurement, inmemory, such as a memory configured as a data logger as described above.In certain embodiments, analyte data is stored at the frequency of aboutonce per minute, or about once every ten minutes, or about once an hour,etc. Data logger embodiments may store historical analyte data for apredetermined period of time, e.g., a duration specified by a physician,for example, e.g., about 1 day to about 1 month or more, e.g., about 3days or more, e.g., about 5 days or more, e.g., about 7 days or more,e.g., about 2 weeks or more, e.g., about 1 month or more.

Other durations of time may be suitable, depending on the clinicalsignificance of the data being observed. The analyte monitoring system100 may display the analyte readings to the subject during themonitoring period. In some embodiments, no data is displayed to thesubject. Optionally, the data logger can transmit the historical analytedata to a receiving device disposed adjacent, e.g., in close proximityto the data logger. For example, a receiving device may be configured tocommunicate with the data logger using a transmission protocol operativeat low power over distances of a fraction of an inch to about severalfeet. For example, and without limitation, such close proximityprotocols include Certified Wireless USB™, TransferJet™, Bluetooth®(IEEE 802.15.1), WiFi™ (IEEE 802.11), ZigBee® (IEEE 802.15.4-2006),Wibree™, or the like.

The historical analyte data set may be analyzed using various diagnosticapproaches. For example, the historical analyte data taken over severaldays may be correlated to the same date/and or time. The historicalanalyte data may be correlated to meal times. For example, data couldtake into account breakfast, lunch, and dinner. Data analysis for eachmeal could include some pre-prandial time (e.g. 1 or 2 hours) and somepost-prandial time (e.g. 1-4 hours). Such an approach eliminatesapparent glucose variability due to variability in the timing of mealsalone. Analyte data parameters may be determined based upon the rate ofchange of one or more analyte levels. In some embodiments, an analytedata parameter may be determined concerning whether a threshold relatingto an analyte value is exceeded, e.g., a hyper- or hypoglycemiacondition, the percentage of time in which the threshold is exceeded, orthe duration of time in which the threshold is exceeded.

The analyte data parameters may be computed by a processor executing aprogram stored in a memory. In certain embodiments, the processorexecuting the program stored in the memory is provided in dataprocessing module 160 (FIG. 1). In certain embodiments, the processorexecuting the program stored in the memory is provided in display device120. An exemplary technique for analyzing data is the applied ambulatoryglucose profile (AGP) analysis technique.

Additional detailed descriptions are provided in U.S. Pat. Nos.5,262,035; 5,264,104; 5,262,305; 5,320,715; 5,593,852; 6,175,752;6,650,471; 6,746, 582, 6,284,478, 7,299,082, and in U.S. patentapplication Ser. No. 10/745,878, now U.S. Pat. No. 7,811,231; Ser. No.11/060,365, now U.S. Pat. No. 8,771,183, the disclosure of each of whichare incorporated herein by reference.

As described above, in certain aspects of the present disclosure,discrete glucose measurement data may be acquired on-demand or uponrequest from the display device, where the glucose measurement isobtained from an in vivo glucose sensor transcutaneously positionedunder the skin layer of a user, and further having a portion of thesensor maintained in fluid contact with the ISF under the skin layer.Accordingly, in aspects of the present disclosure, the user of theanalyte monitoring system may conveniently determine real time glucoseinformation at any time, using the RFID communication protocol asdescribed above.

FIGS. 30A-30D illustrate embodiments of the analyte data acquisitionmodule for use with display device 120 in certain embodiments. Referringto FIGS. 30A-30D, display device 120 may include an input mechanism suchas a user actuatable button 3001 positioned on an outer surface of thehousing of the display device 120. While the embodiment shown in FIG.30C positions the button 3001 on the opposing surface of display device120 as the location of display 122 (FIG. 1), in certain embodiments, thebutton 3001 may be positioned along any suitable axis along a length ora width dimension of display device 120, as long as the button 3001 canbe easily accessed by either hands of the user to provide ambidextrousoperation of button 3001. That is, in certain embodiments, displaydevice 120 may be provided with an input mechanism such as useractuatable button 3001 positioned on its housing such that the button iswithin comfortable and convenient reach for activation, regardless ofwhether the display device 120 is held in the left hand or the righthand of the user.

For example, button 3001 may be positioned on the opposing surface of orthe back housing of display device 120 such that it is locatedsubstantially equidistant from either side edges of the display device120 housing. That is, in certain embodiments, the position of the button3001 is substantially in alignment with the central longitudinal axis ofthe display device 120. In certain embodiments, button 3001 may bepositioned along the upper outer peripheral edge surface of the displaydevice 120 such that it is located at substantially the oppositelocation to the location of the strip port 124 on the display device120. While several specific locations and positions of button 3001 aredescribed above, within the scope of the present disclosure, button 3001may be positioned in other suitable location of the display device 120,including, for example, on the same planar surface of the housing asdisplay 122 of display device 120.

In certain embodiments, actuation of the button 3001 on display device120 initiates one or more routines that are programmed in the displaydevice 120. For example, actuation of button 3001 may initiate theroutine for wireless turn on of the on body electronics 110 as describedabove. In certain embodiments, actuation of button 3001 executes thesoftware routine to initiate data transfer request to acquire analyterelated data from on body electronics 110 (FIG. 1), when the displaydevice 120 is positioned within the predetermined distance from the onbody electronics 110 to receive the data communication. In still otherembodiments, actuation of button 3001 initiates the backlight functionto illuminate the display 122 of display device 120. Button 3001 mayalso be programmed as a power on/off switch. Within the scope of thepresent disclosure, other functions of display device 120 may beassociated with the actuation of button 3001.

Referring back to FIGS. 30A-30D, in certain embodiments, a mateablesleeve 3010 may be provided to couple to the display device 120. Incertain embodiments, electrical contact with display device 120 may beachieved by accessing the battery compartment of display device 120.More specifically, with battery compartment cover 3040 of display device120 removed as shown in FIG. 30A, the exposed battery contacts ofdisplay device 120 may be connected to corresponding electrical contactsin sleeve 3010 when mated with display device 120. After mating withdisplay device 120, actuation of button 3011 on the sleeve 3010activates or initiates the routines similar to those discussed above inconjunction with button 3001 on the housing of display device 120. Asshown in the Figures, in certain embodiments, the sleeve 3010 may bemated with display device 120 to electrically connect with the batterycompartment contacts by securing the sleeve 3010 over one end of thedisplay device 120 as shown and displaced in the direction indicated bydirectional arrow 3012. In certain embodiments, sleeve 3010 may be matedwith display device 120 by applying pressure upon its surface againstthe display device 120 housing, and secure thereon in a snap fit manner.In certain other embodiments, magnetic force or other coupling mechanismmay be used to mate the sleeve 3010 with the display device 120.

In certain embodiments, housing of the sleeve 3010 may be provided withprocessing electronics including antenna, storage device such as memory,and application logic and/or microprocessor for processing data andcommunicating with the on body electronics 110. Accordingly, when matedor coupled to another electronic device such as, for example, an invitro glucose meter, the programmed routines and executable softwarestored in the sleeve 3010, for example, to communicate with on bodyelectronics 110 in analyte monitoring system described above inconjunction with FIG. 1, glucose meter with the mated sleeve 3010 incertain embodiments may communicate with such devices by sharing thestored software routine in sleeve 3010 with one or more microprocessorsof the in vitro glucose meter and executed or implemented by the glucosemeter microprocessor(s).

Furthermore, when the user does not wish to use the sleeve 3010, it canbe disabled or deactivated while engaged to display device 120 orremoved from the display device by sliding or otherwise disengaging themodule 3010 from the display device 120, e.g., moving it in the oppositedirection from the directional arrow shown in 3012 or otherwise simplydetaching the sleeve 3010 from display device 120.

In the manner described above, in accordance with various embodiments ofthe present disclosure, discrete glucose measurements may be obtainedwithout the need for lancing or performing fingerprick test for accessto blood sample each time a measurement is desired. The analytemonitoring system described in further aspects may be configured to logor store glucose data monitored by the analyte sensor continuously overa predetermined or programmable time period, or over the life of thesensor without user intervention, and which data may be retrieved at alater time as desired. Furthermore, output indications such as audible,visual or vibratory alerts may be provided to inform the user of apredetermined condition or when the monitored glucose level deviatesfrom a predefined acceptable range (for example, as warning indicationof low glucose or high glucose level).

In still another aspect, the methods, devices and systems describedabove may be configured to log and store (for example, with anappropriate time stamp and other relevant information such as, forexample, contemporaneous temperature reading) the real time analyte datareceived from the analyte sensor, and may be configured to provide thereal time analyte data on-demand by using, for example a device such asa blood glucose meter or a controller discussed above that is configuredfor communication with the on body integrated sensor and sensorelectronics component.

That is, in one embodiment, real time data associated with the analytebeing monitored is continuously or intermittently measured and stored inthe integrated on body sensor and sensor electronics component, and uponrequest from another device such as the receiver unit or the displaydevice 120 (operated by the user, for example) or any othercommunication enabled device such as a cellular telephone, a PDA, aninternet or WiFi data network enabled smartphones, or any other suitablecommunication enabled device which may be used to receive the desiredanalyte data from the on body integrated sensor and sensor electronicscomponent while being worn and used by the user. In one aspect, suchcommunication enabled device may be positioned within a predeterminedproximity to the integrated on body sensor and sensor electronicscomponent, and when the communication enabled device is positionedwithin the predetermined proximity, the data from the integrated on bodysensor and sensor electronics component may be provided to thecommunication enabled device. In one aspect, such data communication mayinclude inductive coupling using, for example, electromagnetic fields,Zigbee® protocol based communication, or any other suitable proximitybased communication techniques. In this manner, glucose on-demand modemay be provided such that the information associated withcontemporaneously monitored analyte level information is provided to theuser on-demand from the user.

In this manner, in certain embodiments, the size and dimension of the onbody electronics may be optimized for reduction by, for example,flexible or rigid potted or low pressure/low temperature overmoldedcircuitry that uses passive and active surface mount devices forsecurely positioning and adhering to the skin surface of the user. Whenflexible circuitry is with or in the overmold, the on body electronicsmay include the analyte sensor and/or other physiological conditiondetection sensor on the flex circuit (or PCB). Furthermore inembodiments of the present disclosure, one or more printed RF antennamay be provided within the sensor electronics circuitry for RFcommunication with one or more remote devices, and further, the deviceoperation and/or functionalities may be programmed or controlled usingone or more a microprocessors, or ASICs to reduce the number of internalcomponents.

Embodiments of the present disclosure include one or more low pressuremolding materials that directly encapsulate the integrated circuits orthe sensor electronic components. The thermal process entailed in theencapsulation using the low pressure molding materials may be configuredto shield temperature sensitive components such as, for example, theanalyte sensor or other components of the sensor electronics from theheat generated during the thermal overmolding process. Other techniquessuch as injection molding and/or potting may be used.

In another aspect, the sensor electronics may be molded using opticaltechniques such as with a UV cured material, for example, or using twophoton absorption materials, which may also be used to reduce the deador unused volume surrounding the sensor electronics within the housingof the device such that the reduction of its size and dimension may beachieved. Moreover, the sensor electronics may be configured to reducethe number of components used, for example, by the inclusion of an ASICthat may be configured to perform the one or more functions of discretecomponents such as a potentiostat, data processing/storage,thermocouple/thermistor, RF communication data packet generator, and thelike. Additionally, a field programmable gate array (FPGA) or any othersuitable devices may be used in addition to the ASIC in the sensorelectronics to reduce the on body electronics dimension.

Also, embodiments of the present disclosure includes analyte sensorsthat may be fabricated from flex circuits and integrated with the sensorelectronics within the device housing, as a single integrated device.Example of flex circuits may include evaporated or sputtered gold onpolyester layer, single or multi-layer copper or gold on polyimide flexcircuit. When the sensor fabricated from a copper or gold polyimide flexcircuit, gold or other inert material may be selectively plated on theimplantable portion of the circuit to minimize the corrosion of thecopper. In certain embodiments, the flex circuit may be die or lasercut, or alternatively chemically milled to define the sensor from theflex circuit roll.

A further configuration of embodiments of the present disclosureincludes RF communication module provided on the flex circuit instead ofas a separate component in the on body electronics. For example, the RFantenna may be provided directly on the flex circuit by, such assurrounding the on body electronics components within the housing on theflex circuit, or folded over the components, and encapsulated with theelectronic components within the housing of the on body electronics.

In one aspect, the integrated assembly including the on body electronicsand the insertion device may be sterilized and packaged as one singledevice and provided to the user. Furthermore, during manufacturing, theinsertion device assembly may be terminal packaged providing costsavings and avoiding the use of, for example, costly thermoformed trayor foil seal. In addition, the insertion device may include an end capthat is rotatably coupled to the insertion device body, and whichprovides a safe and sterile environment (and avoid the use of desiccantsfor the sensor) for the sensor provided within the insertion devicealong with the integrated assembly. Also, the insertion device sealedwith the end cap may be configured to retain the sensor within thehousing from significant movement during shipping such that the sensorposition relative to the integrated assembly and the insertion device ismaintained from manufacturing, assembly and shipping, until the deviceis ready for use by the user.

In certain embodiments, an integrated analyte monitoring device assemblycomprises an analyte sensor for transcutaneous positioning through askin layer and maintained in fluid contact with an ISF under the skinlayer during a predetermined time period. The analyte sensor includes aproximal portion and a distal portion. The integrated analyte monitoringdevice assembly includes on body electronics coupled to the analytesensor, the on body electronics comprising a circuit board having aconductive layer and a sensor antenna disposed on the conductive layer,one or more electrical contacts provided on the PCB and coupled with theproximal portion of the analyte sensor to maintain continuous electricalcommunication, and a data processing component provided on the circuitboard and in signal communication with the analyte sensor. The dataprocessing component may be configured to execute one or more routinesfor processing signals received from the analyte sensor, and to controlthe transmission of data associated with the processed signals receivedfrom the analyte sensor to a remote location using the sensor antenna inresponse to a request signal received from the remote location.

Various other modifications and alterations in the structure and methodof operation of this disclosure will be apparent to those skilled in theart without departing from the scope and spirit of the embodiments ofthe present disclosure. Although the present disclosure has beendescribed in connection with particular embodiments, it should beunderstood that the present disclosure as claimed should not be undulylimited to such particular embodiments. It is intended that thefollowing claims define the scope of the present disclosure and thatstructures and methods within the scope of these claims and theirequivalents be covered thereby.

What is claimed is:
 1. An apparatus, comprising: an analyte sensorhaving a portion configured to be in fluid contact with bodily fluidunder a skin surface and configured to generate signals corresponding tomonitored analyte level in the bodily fluid; a power supply; a datastorage unit for storing analyte sensor calibration information, theanalyte sensor calibration information including a factory calibrationvalue for calibrating data for the generated signals corresponding tothe monitored analyte level in the bodily fluid, wherein the factorycalibration value is not modified during the entire period of theanalyte sensor usage life; and sensor electronics operatively coupled tothe analyte sensor and the power supply, the sensor electronicsincluding a communication component configured to receive the signalsgenerated by the analyte sensor and one or more other components togenerate one or more data packets including the received signals fromthe analyte sensor; wherein the sensor electronics is configured tooperate in a first mode wherein the communication component is in a lowpower state while the sensor electronics draw power from the powersupply to operate the one or more other components; and wherein thesensor electronics is configured to switch from operating in the firstmode into operating in a second mode for the sensor electronics to drawpower from radio frequency (RF) power of a remote device and to operatethe communication component only using the power drawn from the RF powerof the remote device to transmit the generated one or more data packetsto the remote device, while the sensor electronics is simultaneouslydrawing the power from the power supply to operate the one or more othercomponents.
 2. The apparatus of claim 1, wherein the sensor electronicsis configured to begin drawing the power from the RF power of the remotedevice when a predetermined level of RF power is detected.
 3. Theapparatus of claim 2, wherein the sensor electronics only uses the powerdrawn from the power supply to generate the one or more data packets. 4.The apparatus of claim 2, further including a switch connecting thepower supply to the sensor electronics, wherein the switch is open whenthe predetermined level of RF power is detected such that the sensorelectronics begins drawing the power from the RF power of the remotedevice.
 5. The apparatus of claim 4, wherein the switch is closed whenthe predetermined level of RF power is no longer detected by the sensorelectronics such that the sensor electronics only uses the power drawnfrom the power supply.
 6. The apparatus of claim 1, further including arechargeable power source operatively coupled to the sensor electronics,wherein when the remote device is positioned within a predetermineddistance from the sensor electronics, the RF power from the remotedevice charges the rechargeable power source.
 7. The apparatus of claim1, wherein the bodily fluid includes one of dermal fluid or interstitialfluid.
 8. The apparatus of claim 1, wherein the analyte sensor includesa plurality of electrodes including a working electrode comprising ananalyte-responsive enzyme bonded to a polymer disposed on the workingelectrode.
 9. The apparatus of claim 8, wherein the analyte-responsiveenzyme is chemically bonded to the polymer disposed on the workingelectrode.
 10. The apparatus of claim 8, wherein the working electrodecomprises a mediator bonded to the polymer disposed on the workingelectrode.
 11. The apparatus of claim 10, wherein the mediator iscrosslinked with the polymer disposed on the working electrode.
 12. Theapparatus of claim 1, wherein the analyte sensor includes a plurality ofelectrodes including a working electrode comprising a mediator bonded toa polymer disposed on the working electrode.
 13. The apparatus of claim1, wherein the entire period of the analyte sensor usage lifecorresponds to a time period of monitoring the analyte level in thebodily fluid, and starts when the sensor electronics is activated, andends when the sensor electronics is deactivated.
 14. The apparatus ofclaim 13, wherein the sensor electronics is deactivated when noadditional signals from the analyte sensor is processed by the sensorelectronics.
 15. The apparatus of claim 1, wherein the data storage unitis further for storing an identification information.
 16. The apparatusof claim 15, wherein the sensor electronics is operatively coupled tothe data storage unit, and the generated one or more data packetsinclude the identification information and the analyte sensorcalibration information.
 17. The apparatus of claim 1, wherein the oneor more other components comprise a processing component.
 18. Theapparatus of claim 1, wherein the sensor electronics draws power fromthe RF power of the remote device, and the communication componenttransmits the generated one or more data packets to the remote device,at a range of 5 inches or less.
 19. A system, comprising: a subcutaneousanalyte sensor in contact with bodily fluid and configured to generatesignals corresponding to monitored analyte level in the bodily fluid; adisplay device configured to generate an electromagnetic field forcommunication; and sensor electronics communicatively coupled to theanalyte sensor to receive the generated signals from the analyte sensorand in response generate one or more data packets including the receivedsignals, the sensor electronics comprising: a rechargeable power source,a processor and a communication component for communicating with thedisplay device using the electromagnetic field, the sensor electronicsfurther configured to draw power from the power source and theelectromagnetic field generated by the display device, wherein thesensor electronics is configured to operate in a first mode wherein thecommunication component is in a low power state while the sensorelectronics draw power from the power source to operate the processor togenerate the one or more data packets, and to switch the communicationcomponent into an operational mode wherein the communication componentis powered only using the power drawn from the electromagnetic field soas to transmit the generated one or more data packets to the displaydevice while the sensor electronics is simultaneously drawing the powerfrom the power source to operate the processor, and wherein the sensorelectronics is configured to generate the one or more data packets onlyusing power drawn from the rechargeable power source.
 20. The system ofclaim 19, wherein the power source of the sensor electronics does nothave an electrical connection with the communication component of thesensor electronics.